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AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK ACRIN PA 4008 Arterial Stiffness and Wave Reflections as Determinants of Regression of Left Ventricular Hypertrophy and Fibrosis Assessed with Cardiac MRI After Aortic Valve Replacement for Severe Aortic Stenosis [Note: The American College of Radiology Imaging Network (ACRIN) complies with the privacy measures put forth by the Health Insurance Portability and Accountability Act (HIPAA). However, ACRIN does not monitor compliance with HIPAA; that is the responsibility of the local institutions and their Institutional Review Boards (IRBs). Local IRBs may choose to combine the authorization elements in the informed consent.] This is a clinical study, a type of research study. Research staff will explain the clinical study to you. Clinical studies include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You can also discuss it with your health care team. If you have any questions, you can ask your study doctor or other research staff for more explanation. If you decide to do this study, you will be asked to sign and date this form. You are being asked to be in this study because you have heart disease that needs surgery called an aortic valve replacement. The people who will join this study have severe heart disease called aortic stenosis, which means a valve that helps blood flow in and out of your heart does not open fully. Your treating doctors agree that your treatment would benefit from a clearer picture of your heart disease. To join the study, you must be willing to have two magnetic resonance imaging (MRI) scans of your heart and agree to have your heart and kidneys checked beforehand to ensure joining the study is safe for you. You also must be willing to allow research staff to contact you in the future about this study and your overall health. The MRI scans of your heart for the study are in addition to your routine care. WHY IS THIS STUDY BEING DONE? The study doctors running this study want to use MRI technology to measure the framework of your heart before and after the surgery to replace your aortic valve. They believe these measurements will help them determine how someone will do after surgery, and may even show a new means of helping treat people who may not do well after valve replacement surgery. The results will be shared with you, and you may share them with your treating doctor. The results may or may not be of benefit to you. The study doctors will evaluate the importance of stiffness of the arteries in being able to determine how the heart is doing after surgery. As your body heals around the area where your heart valve was repaired sometimes enlargement of the heart, thickening of the heart muscle, and scarring (called fibrosis) can occur. This study will look at how MR images of the heart can show these changes in the heart after surgery. The hope is that a better understanding of these changes will lead study doctors and future researchers to new ways to treat people with heart disease who may not do well after valve replacement surgery. ACRIN PA 4008 1 October 31, 2012 In addition, this study will look at a new heart MRI technique that may be used in the future to measure scarring (fibrosis) in heart muscle. This new technique might be safer for people who cannot undergo an MRI with a contrast agent because of poor kidney function. About Contrast Agents Contrast agents are liquid-like dyes that go into the body to help imaging machines, like an MRI, create pictures of the body’s organs and bones. The contrast agent gadolinium will be used in this study to help create clear pictures of your heart. Gadolinium could cause damage if you have kidney disease. Your kidney function will be tested. You may not be able to participate if you have poor kidney function. Gadolinium is approved by the FDA and is commonly used with MRI scans in patients with no kidney disease. If you participate in this study, you will be given 0.15 mmol/kg of gadolinium instead of the usual 0.10 mmol/kg. The increase in amount is small and does not significantly increase the risks associated with gadolinium. If you have any questions, please ask your treating doctor. About MRI Scans You are being asked to have two MRI scans of your heart for this study because you have heart disease that requires surgery. An MRI uses powerful magnets and radio waves linked to a computer to create cross-sectional images of the body. For this study, the MRI images will provide a clear and detailed view of the heart. HOW MANY PEOPLE WILL TAKE PART IN THE STUDY? A total of 80 people will take part in this study at participating sites with the imaging technology needed to do the study. HOW LONG WILL I BE IN THE STUDY? We think you will be in the study for a minimum of seven (7) months from the time you sign this consent form. The study doctors hope that funding will be available in the future to ask some questions that would require longer-term contact with you to see how you’re doing. When you sign this form, you agree to being contacted by telephone in the future (for up to 5 years after your 6-month MRI scan of your heart) about studies that are related to what is found during this study. In addition, you agree to allow the study doctors to search the National Death Index, which lists when people pass away, for future research studies. If you should change your mind about someone contacting you in the future you will need to send a signed and dated written letter saying you do not wish to be contacted about future studies. This study is expected to end after all study participants have completed the study-related visits and all information has been collected. This study may be stopped at any time by your study doctor, ACRIN, Food and Drug Administration (FDA), or Pennsylvania Department of Health (PA DoH) without your consent because: Your health or safety may be at risk; You have not been following study instruction; Of an administrative decision by ACRIN, the study doctor, FDA, or the PA DoH; New information becomes available; Funding is terminated. ACRIN PA 4008 2 October 31, 2012 These actions do not require your consent, but you will be informed of any of these decisions if such a decision is made. You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the study doctor and your treating doctor first. Choosing to withdraw from the study will not interfere with your future care. The study doctors do not think there will be any serious effects on your health if you withdraw from the study. WHAT AM I BEING ASKED TO DO IN THE STUDY? After signing this consent form, research staff may need to take some blood from you to test your kidney function, if you have not had this blood test in the last four (4) weeks before you join the study. This study hopes to identify potentially-treatable changes that may be seen on heart MRI before and after your valve replacement surgery. Therefore, if you choose to join the study, you are being asked to have two (2) heart MRI studies, one within 21 days (three [3] weeks) before your aortic valve replacement surgery and a second six (6) months after surgery. If you take part in this study, you will have the following tests and procedures: Two (2) separate magnetic resonance imaging scans (MRIs) of your heart at the hospital. Both scans will require an intravenous (IV) injection of contrast agent (“dye”). The MRI scans of your heart will be done in a regular MRI machine. Each scan takes about 1 hour and does not involve radiation. Some people do not like MRI scans. If you are claustrophobic, please let us know now. The MRI scanner is noisy. Everyone is offered headphones or ear plugs. You can listen to music if you want to. Some new MRI techniques will be used in this study. We have every reason to believe these MRI techniques are safe and several humans have been scanned with them before. However, there could be risks that we do not know about at this time, although this is extremely unlikely. Your MRIs will be done with a contrast agent (“dye”) called gadolinium, which allows the study doctors to see your heart better. We will use gadolinium twice in this study (with each MRI—at the beginning of the study then again six (6) months after the aortic valve replacement surgery). Two (2) separate arterial tonometry procedures. You will be asked to undergo a procedure known as arterial tonometry. Arterial tonometry is a simple and quick test that uses a pencil-like device (called a tonometer) to examine the pressure and movement in your blood vessels. This test will allow the study doctors to determine: the stiffness of your arteries, how waves travel in the arteries, and how much pressure the heart is pumping against. This test will be done by a trained member of the research team and will take about 20 minutes. The procedure will be done immediately after each of the two study-related MRI scans. Research staff will place a blood pressure cuff around your arm. The cuff will be slowly inflated and then slowly deflated. This is done to record blood pressure. ACRIN PA 4008 3 October 31, 2012 Sticker-like electrodes will be placed over your skin on the chest to measure the electrical current generated by your heart. Next, research staff will gently put the tonometer (pencil-like device) against your arm and wrist, then over the side of your neck and finally on top of a blood vessel in your groin area. This test will not break your skin, should not cause pain, and should not cause any major discomfort. Two (2) separate blood draws. For each of two (2) blood draws, a needle will be placed in a vein in your arm and three (3) vials of blood will be drawn. Some of this blood may be used to measure your kidney function to see if you can receive the contrast agent gadolinium so that the MRI can be performed safely. In addition, we will measure your hematocrit (the percentage of red blood cells in your blood) in order to better interpret the MRI images. The rest of your blood will be used to measure various circulating biomarkers (substances in the blood) which may give us information about the status of your heart and blood vessels. Three (3) vials of blood will be collected each time, for a total of about 15 to 30 mL. Any of your blood that is left over from your blood tests for this study will be kept for a maximum of five (5) years. Your blood may be used to study any new blood tests developed during that 5 year period. Results from the new blood test will be compared and included with results from this study. You will not be identified in any reports of the results. You will not receive any results from future studies. After the 5 years, your leftover blood will be destroyed. Two (2) separate medical history assessments: We will ask you questions about your symptoms and collect information from your medical record, such as the results of blood tests and findings of recent heart tests. Information collected from your medical record will be related to your heart health. All your information will be handled confidentially as per your institutional and protocol standards. You will be asked about your day’s activities prior to undergoing the MRI scan. You should take your medications as prescribed during the day of your MRI scan. You should avoid smoking, food, and alcohol for four (4) hours prior to your scheduled MRI scans; avoid caffeinated drinks for 24 hours. Your MRI scan may need to be rescheduled if you have to take a nitrate the day of your scan. One (1) quality of life questionnaires to complete at two different times. The questionnaire will measure how your heart condition is impacting your quality of life. This questionnaire is called the Kansas City Cardiomyopathy Questionnaire (KCCQ). This takes approximately five (5) minutes. One (1) 6-minute walk test. For the 6-minute walk test, you will walk as long a distance as possible during six (6) minutes. Six minutes is a long time to walk, so you will be exerting yourself. You will probably get out of breath or become exhausted. You are permitted to slow down, to stop, and to rest as necessary. In this test, we want to measure how fit you are. We will do this ACRIN PA 4008 4 October 31, 2012 test once (in the 6-month visit after the surgery). This test takes approximately 10 minutes (although you will walk for exactly 6 minutes). The following study chart explains what is expected of you at each study time point. STUDY CHART VISIT 1: Eligibility and Registration VISIT 2: CARDIAC MRI SCAN 1 *Within the 3 Weeks (21 Days) Before Aortic Valve Replacement Surgery* ACRIN PA 4008 Read and sign this informed consent form (ICF). Have a medical history assessment, including a review of your heart health history, a review of the heart tests you already completed, and a review of the blood tests you may have had to make sure your kidneys are healthy. (If a blood test has not been done within the last month to check your kidney health, a blood draw may be needed). Complete a quality-of-life questionnaire (short, about 5 minutes). If you are a pre-menopausal woman, confirm that you are not pregnant as general practice and per institution’s standard of care. Have the first MRI of your heart scheduled for within the next three (3) weeks (21 days) before your surgery. Have a medical history assessment, including describing your usual medications and whether you have needed a short-acting nitrate on the day of the MRI. If you are a pre-menopausal woman, confirm that you are not pregnant as general practice and per institution’s standard of care. Describe your activities thus far in your day, including any smoking, medications, caffeinated beverages, or alcohol that you may have had. (You should receive instructions to take your medications as you would normally and to avoid smoking, food, and alcohol for four [4] hours before the MRI scan and caffeinated beverages for 24 hours.) Have an intravenous (IV) line placed in your arm for the injection of the contrast agent gadolinium. Have about three (3) vials (15 to 30 mL) of blood taken. Have an MRI of your heart using the contrast agent gadolinium. Have an arterial tonometry study. You will be contacted by the research staff within 24 to 72 hours after the MRI of your heart to see how you are doing. 5 October 31, 2012 VISIT 3: CARDIAC MRI SCAN 2 *About Six (6) Months After Aortic Valve Replacement Surgery* Have a medical history assessment, including describing your usual medications and whether you have needed a short-acting nitrate on the day of the MRI. Complete a quality-of-life questionnaire (short, about 5 minutes). If you are a pre-menopausal woman, confirm that you are not pregnant as general practice and per institution’s standard of care. Describe your activities thus far in your day, including any smoking, medications, caffeinated beverages, or alcohol that you may have had. (You should receive instructions to take your medications as you would normally and to avoid smoking, food, and alcohol for four [4] hours before the MRI scan and caffeinated beverages for 24 hours.) Have an intravenous (IV) line placed in your arm for the injection of the contrast agent gadolinium. Have about three (3) vials (15 to 30 mL) of blood taken. Have an MRI of your heart using the contrast agent gadolinium. Have an arterial tonometry study. Walk for six (6) minutes. The objective of the test is to walk as far as possible in 6 minutes. The 6-Minute Walk Test is useful to measure how well people with severe aortic stenosis are doing. You will be contacted by the research staff within 24 to 72 hours after the MRI of your heart to see how you are doing. WHAT ARE THE POSSIBLE RISKS OR DISCOMFORTS OF THE STUDY? While on the study, you may be at risk for the following side effects. You should discuss these risks with your study doctors and/or treating doctors. There also may be other side effects that we cannot predict. If you should experience side effects, drugs may be given to make side effects less serious and uncomfortable. Many side effects go away shortly after the study test or procedure is stopped. In some cases side effects can be serious, long lasting, or permanent, but serious side effects are rare. Likely Occurrences/Risks from Study Tests and Procedures This is a list of the likely risks that may occur during this study: The most commonly reported side effects for gadolinium include: nausea, headache, dizziness, low blood pressure, and taste changes. The heart MRI for the study may cause you anxiety, stress, claustrophobia (fear in small places), or discomfort. If you have a history of claustrophobia, tell the research staff. ACRIN PA 4008 6 October 31, 2012 During the 6-Minute Walk Test you may get out of breath or become exhausted. You are encouraged to slow down, to stop, and to rest as is necessary. Minor discomfort may occur when a wand (tonometer) is placed against your neck during the arterial tonometry studies. We will use adhesive electrodes attached to your skin, which are part of the studyrelated and standard practice tests (echocardiogram, cardiac MRI, or stress test) that your doctor ordered. These may occasionally cause itching and irritation in your skin. There may be minor discomfort or pain (sometimes accompanies by redness, swelling, and warmth to the area) from the injection needle(s) to collect blood and place an intravenous (IV) line for the gadolinium contrast. Less likely, some bleeding or bruising may occur from the injection needle or when the vein punctures to draw blood for the study. Fainting and infection are also less likely. Rare Occurrences/Risks from Study Tests and Procedures This is a list of the rare risks that may occur during this study: Research staff will ask if you have any metal anywhere in your body. If you should have the MRI without informing research staff about metal in your body, it may cause serious injury. Some people with severely reduced kidney function have developed a potentially fatal skin disease called nephrogenic systemic fibrosis [NSF] from the gadolinium being used in this study. Psychological risks are very rare in this study. The 6-Minute Walk Test could result in cardiovascular collapse. Although extremely rare because the test will be closely monitored, we ask that you walk within your physical abilities. You are best aware of your physical capabilities. There is a minimal risk of breach of confidentiality, since research staff will have access to some of your health information. The research team will take appropriate measures to minimize this risk. Reproductive Risks: If you are pregnant or nursing or plan to become pregnant during the course of the study, you cannot take part in this research study. We do not know the effects of the MRI of your heart on the fetus, breast-feeding baby, or mother-to-be, and this study may cause harm. Because the gadolinium used in this study may affect an unborn baby, you should not become pregnant or father a baby while on this study. You should not nurse your baby while on this study. During the study you need to take safety measures to prevent pregnancy by not having sex or by using medically accepted method of birth control such as a diaphragm, cervical cap, condom, surgical sterility, and/or birth control pills. If you or your partner should become pregnant, you will need to tell your study doctor immediately. Ask your study doctor about counseling and more information about preventing pregnancy. ACRIN PA 4008 7 October 31, 2012 The study doctors and research staff do not believe there are significant economical, social, mental, and/or emotional risks related to this study. In addition to the possible risks detailed above, the research may involve risks that are currently unforeseeable. For more information about risks and side effects, ask your study doctor and other research staff. WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART IN THE STUDY? If you agree to take part in this study, there may or may not be direct medical benefit to you. We hope the information learned from this study will benefit other patients with aortic stenosis and other heart diseases diagnosed in the future. WHAT OTHER CHOICES DO I HAVE IF I DO NOT WANT TO PARTICIPATE? You may choose not to take part in this study. If you choose not to participate, there will be no penalty and your treatment/medical care will not be affected. Your treating doctor can tell you the different available options for imaging your heart before and/or after your surgery. WILL MY MEDICAL INFORMATION BE KEPT PRIVATE? We will do our best to make sure that your personal information will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. Records of your participation on this study, your progress, and images submitted (such as the MRI scans of your heart) while you are on the study will be kept in a confidential form at <<Institution>> and in a computer file at the headquarters of the American College of Radiology Imaging Network (ACRIN) in Philadelphia. All data sent to ACRIN over the Internet will be coded so that other people cannot read it. All personal identifiers are removed and replaced with a unique identifying number. You further understand and agree that authorized representatives of ACRIN, the Food and Drug Administration (FDA), the Pennsylvania Department of Health (PA DoH) and its agents and contractors, the Institutional Review Board (IRB) of <<Institution>> and other groups or organizations that have a role in this study may, without obtaining additional consent from you, have access to and copy both your medical and research records, including the results of your participation in this study. This access is necessary to ensure the accuracy of the findings, the completion of the study, and your safety and welfare. If any publication or presentations result from this study, you will not be identified by name. Results will be reported in a summarized manner in which you cannot be identified. A description of this clinical study will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY? Taking part in this study may lead to added costs to you or your insurance company. Please ask your study doctor about any expected added costs or insurance problems. You will not be responsible for the costs of any examinations, tests, or procedures that are considered part of the study and not part of standard care, such as both MRIs of your heart and both blood tests and blood collections. However, you and/or your health insurance will be charged for any portion of your care that is considered standard care (that is, if these expenses ACRIN PA 4008 8 October 31, 2012 would have happened even if you were not in the study) or if your insurance agrees in advance to pay. You may be responsible for any co-payments and deductibles that are standard for your insurance coverage. You and/or your insurance company will be charged for continuing medical care and/or hospitalization, including emergency medical care. WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS STUDY? It is important that you tell your study doctor, <<insert name>>, if you feel that you have been injured because of taking part in this study or if any medical emergency, injury, or illness occurs during this study. You can tell the study doctor in person or call him/her at <<insert telephone number>>. In the case of medical emergency, injury, or illness during this study, emergency medical treatment is available but will be provided at the usual charge. You and/or your insurance will be responsible for the cost of the medical care of that illness or injury. There is no financial compensation that has been set aside to compensate you in the event of injury. WILL I BE PAID FOR BEING IN THIS STUDY? SITE SPECIFIC: <<This section should describe any monetary compensation, if participants are being compensated for their time and travel. An itemized amount of the total monetary compensation ($ amount per each visit/procedure or upon completion of the study) should be documented here. Parking and other vouchers, meal tickets, and transportation reimbursements are examples of compensation to be described here.>> Clinical study conduct allows reasonable reimbursement for travel expenses and time away from work associated with study participation. If you are eligible to enroll in the study, you will receive a total of $<<Institution to provide appropriate amount—sites can determine a per-visit rate of $45 to $75 based upon appropriateness for their institution >> upon completion of the study as compensation for time and travel associated with your participation in this research study. If, for whatever reason, you do not complete the study-related imaging scans, you will be given $<<Institution to provide appropriate amount—sites can determine a per visit rate of $45 to $75 based upon appropriateness for their institution>> per each study-related scan completed. WHAT ARE MY RIGHTS AS A PARTICIPANT? Taking part in this study is your choice. You may choose not to take part in the study. If you do decided to participate, you are free to leave the study at any time. No matter what decision you make, there will be no penalty to you, and you will not lose any of your regular treatment and medical care options now or in the future. You can still get your medical care from our institution. During the study, we may find out more information that could be important to you. A Data and Safety Monitoring <<Board/Committee>> (an independent group of experts) will be reviewing the data from this research throughout the study. This includes information that might cause you to change your mind about being in the study. If information becomes available from this or other studies that may affect your health, welfare, or willingness to stay in this study, we will tell you about it as soon as possible. ACRIN PA 4008 9 October 31, 2012 WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? (This section must be completed) This document explains your rights as a study participant. It you have any questions regarding your participation in this research study or you have any questions regarding your rights as a research participant, do not hesitate to speak with your study doctor or anyone listed below. You can talk to your study doctor about any questions or concerns you have about this study. Contact your study doctor, <<insert name>>, at <<insert telephone number>>. For additional information about your health or medical emergency, you may contact: <<Usually the name of the local hospital information is provided and with instructions to study participants to inform the ER doctor of their participation in a clinical trial.>> Name Telephone Number For information about this study, you may contact: Name Telephone Number For questions about your rights while taking part in this study call the <<insert name IRB contact person>> at <<insert name of the IRB>> Institutional Review Board (a group of people who review the research to protect your rights) at <<insert telephone number>>. <<Provide the name of a local IRB contact person.>> Name Telephone Number ACKNOWLEDGEMENT When you sign this document, you are agreeing to take part in this study. This means you have read all the above information, asked questions regarding your participation, and received answers that you understand to all your questions. You also have had the opportunity to take this consent form home for review or discussion if you want to. A copy of the signed consent will be given to you. You willingly give your consent to participate in this study. _ Printed Name of Study Participant/ Legal Representative Signature Date <<Add other signatory lines as required by local IRBs.>> ACRIN PA 4008 10 October 31, 2012 APPENDIX II: SUPPLEMENTAL MATERIALS AVAILABLE ONLINE ACRIN PA 4008 Supplemental materials that support the conduct of the study are available on the ACRIN Web site at the ACRIN PA 4008 Protocol web page (www.acrin.org/4008_protocol.aspx). Types of materials posted online include: Application and protocol activation documents (General Qualifying and Protocol Specific Applications, protocol activation checklist, etc.); Data forms; Imaging materials (Image Transmittal Worksheet, imaging parameter charts, image submission instructions, and scanning and image qualification instructions), available directly via www.acrin.org/4008_imagingmaterials.aspx; Recruitment and education materials; Regulatory resources, available directly via www.acrin.org/pdrc.aspx; Participating site list; Blood Sample Instructions Manual for details about sample preparation and delivery; Arterial Tonometry Standard Operating Procedures document supports the content in Appendix IV to the protocol by providing detailed standard operating procedures for the arterial tonometry component of the study (www.acrin.org/4008_imagingmaterials.aspx). For more information related to the study, contact the ACRIN PA 4008 Contact Personnel link on the above-mentioned Web page for a list of protocol team members at ACRIN Headquarters and their roles. ACRIN PA 4008 11 October 31, 2012 APPENDIX III: SIX-MINUTE WALK TEST PROCEDURES ACRIN PA 4008 INDICATION FOR USE IN ACRIN PA 4008 The 6-Minute Walk Test (6MWT) will be used in ACRIN PA 4008 for measuring response to the aortic valve replacement (AVR) surgery among participants with severe aortic stenosis. Any participant with a contraindication to the test will not be required to complete the walk test at the 6-months post-AVR cardiac MRI [Visit 3]). SAFETY ISSUES 1 Testing should be performed in a location where a rapid, appropriate response to an emergency is possible. The appropriate location of a crash cart should be determined by the physician supervising the facility. 2 Supplies that must be readily available include oxygen, sublingual nitroglycerine, aspirin, and albuterol (metered dose inhaler or nebulizer). A telephone or other means of communication with emergency services should be in place to enable a call for help. 3 The research staff performing the test should be certified in cardiopulmonary resuscitation with a minimum of Basic Life Support by an American Heart Association– approved cardiopulmonary resuscitation course. Advanced cardiac life support certification is desirable. Training, experience, and certification in related healthcare fields (registered nurse, registered respiratory therapist, certified pulmonary function technician, etc.) also are desirable. A certified individual should be readily available to respond if needed. 4 Physicians are not required to be present during all tests. The physician ordering the test or a supervising physician may decide whether physician attendance at a specific test is required. 5 If a patient is on chronic oxygen therapy, oxygen should be given at their standard rate or as directed by a physician or a protocol. Reasons for immediately stopping a 6MWT include the following: (1) chest pain, (2) intolerable dyspnea, (3) leg cramps, (4) staggering, (5) diaphoresis, and (6) pale or ashen appearance. Any research staff performing the 6MWT must be trained to recognize these problems and the appropriate responses. If a test is stopped for any of these reasons, the patient should sit or lie supine as appropriate depending on the severity or the event and the research staff's assessment of the severity of the event and the risk of syncope. The following should be obtained based on the judgment of the research staff: blood pressure, pulse rate, oxygen saturation, and a physician evaluation. Oxygen should be administered as appropriate. TECHNICAL ASPECTS OF THE 6MWT Location: Preparing the Walking Space The 6MWT should be performed indoors, along a long, flat, straight, enclosed corridor with a hard surface that is seldom traveled. If the weather is comfortable, the test may be performed outdoors. The walking course is desired to be 30 m in length. A 100-ft hallway is, therefore, recommended. The length of the corridor can be optionally marked every 3 m. The turnaround points should be marked with a cone (such as an orange traffic cone). A starting line, which ACRIN PA 4008 12 October 31, 2012 marks the beginning and end of each 60-m lap, should ideally be marked on the floor using brightly colored tape. Required Equipment 1 Countdown timer (or stopwatch) 2 Mechanical lap counter 3 Two small cones to mark the turnaround points 4 A chair that can be easily moved along the walking course 5 Worksheets on a clipboard 6 A nearby source of oxygen 7 Sphygmomanometer 8 Nearby telephone 9 Nearby automated electronic defibrillator Patient Preparation 1 Comfortable clothing should be worn. 2 Appropriate shoes for walking should be worn. 3 Patients should use their usual walking aids during the test (cane, walker, etc.). 4 The patient's usual medical regimen should be continued. 5 A light meal is acceptable before early morning or early afternoon tests (in consideration of fasting requirements for the cardiac MRI studies). 6 Patients should not have exercised vigorously within 2 hours of beginning the test. MEASUREMENTS/PROCEDURES Before the 6MWT 1 A “warm-up” period before the test should not be performed. 2 The patient should sit at rest in a chair, located near the starting position, for at least 10 minutes before the test starts. During this time, check for contraindications, measure pulse and blood pressure, and make sure that clothing and shoes are appropriate. Complete the first portion of the worksheet (see below). 3 Pulse oximetry is optional. If it is performed, measure and record baseline heart rate and oxygen saturation (SpO2) and follow manufacturer's instructions to maximize the signal and to minimize motion artifact. Make sure the readings are stable before recording. Note pulse regularity and whether the oximeter signal quality is acceptable. ACRIN PA 4008 13 October 31, 2012 4 Have the patient stand and rate their baseline dyspnea and overall fatigue using the Borg scale: The Borg Scale 0 0.5 1 2 3 4 5 6 7 8 9 10 Nothing at all Very, very slight (just noticeable) Very slight Slight (light) Moderate Somewhat severe Severe (heavy) Very severe Very, very severe (maximal) (This Borg scale should be printed on heavy paper [11 inches high and perhaps laminated] in 20-point type size. At the beginning of the 6-minute exercise, show the scale to the patient and ask the patient this: “Please grade your level of shortness of breath using this scale.” Then ask this: “Please grade your level of fatigue using this scale.) Performing the 6MWT 1 Set the lap counter to zero and the timer to 6 minutes. Assemble all necessary equipment (lap counter, timer, clipboard, Borg Scale, worksheet) and move to the starting point. 2 Instruct the patient as follows: “The object of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway. Six minutes is a long time to walk, so you will be exerting yourself. You will probably get out of breath or become exhausted. You are permitted to slow down, to stop, and to rest as necessary. You may lean against the wall while resting, but resume walking as soon as you are able. You will be walking back and forth around the cones. You should pivot briskly around the cones and continue back the other way without hesitation. Now I'm going to show you. Please watch the way I turn without hesitation.” Demonstrate by walking one lap yourself. Walk and pivot around a cone briskly. “Are you ready to do that? I am going to use this counter to keep track of the number of laps you complete. I will click it each time you turn around at this starting line. Remember that the object is to walk AS FAR AS POSSIBLE for 6 minutes, but don't run or jog. Start now, or whenever you are ready.” 3 Position the patient at the starting line. You should also stand near the starting line during the test. Do not walk with the patient. As soon as the patient starts to walk, start the timer. ACRIN PA 4008 14 October 31, 2012 4 Do not talk to anyone during the walk. Use an even tone of voice when using the standard phrases of encouragement. Watch the patient. Do not get distracted and lose count of the laps. Each time the participant returns to the starting line, click the lap counter once (or mark the lap on the worksheet). Let the participant see you do it. Exaggerate the click using body language, like using a stopwatch at a race. After the first minute, tell the patient the following (in even tones): “You are doing well. You have 5 minutes to go.” When the timer shows 4 minutes remaining, tell the patient the following: “Keep up the good work. You have 4 minutes to go.” When the timer shows 3 minutes remaining, tell the patient the following: “You are doing well. You are halfway done.” When the timer shows 2 minutes remaining, tell the patient the following: “Keep up the good work. You have only 2 minutes left.” When the timer shows only 1 minute remaining, tell the patient: “You are doing well. You have only 1 minute to go.” Do not use other words of encouragement (or body language to speed up). If the patient stops walking during the test and needs a rest, say this: “You can lean against the wall if you would like; then continue walking whenever you feel able.” Do not stop the timer. If the patient stops before the 6 minutes are up and refuses to continue (or you decide that they should not continue), wheel the chair over for the patient to sit on, discontinue the walk, and note on the worksheet the distance, the time stopped, and the reason for stopping prematurely. When the timer is 15 seconds from completion, say this: “In a moment I'm going to tell you to stop. When I do, just stop right where you are and I will come to you.” When the timer rings (or buzzes) and 6 minutes has passed, say this: “Stop!” Walk over to the patient. Consider taking the chair if they look exhausted. Mark the spot where they stopped by placing a bean bag or a piece of tape on the floor. After the 6MWT 1 Post-test: Record the post-walk Borg dyspnea and fatigue levels (using the Borg Scale above again) and ask this: “What, if anything, kept you from walking farther?” 2 If using a pulse oximeter, measure SpO2 and pulse rate from the oximeter and then remove the sensor. 3 Record the number of laps from the counter (or tick marks on the worksheet). 4 Record the additional distance covered (the number of meters in the final partial lap) using the markers on the wall as distance guides. Calculate the total distance walked, rounding to the nearest meter, and record it on the worksheet. 5 Congratulate the patient on good effort and offer the person a drink of water. QUALITY ASSURANCE Training and Experience Any research staff performing 6MWTs should be trained using the standard protocol and then supervised for several tests before performing them alone. They should have completed cardiopulmonary resuscitation training. ACRIN PA 4008 15 October 31, 2012 Encouragement Only the standardized phrases for encouragement (as specified previously here) must be used during the test. Supplemental Oxygen If oxygen supplementation is needed during the walks and serial tests are planned (after an intervention other than oxygen therapy), then oxygen should be delivered in the same way with the same. If the flow must be increased during subsequent visits due to worsening gas exchange, this should be noted on the worksheet for use during the 6MWT and reported in the appropriate ACRIN electronic case report form. The type of oxygen delivery device also should be noted on the report: for instance, the patient carried liquid oxygen or pushed or pulled an oxygen tank, the delivery was pulsed or continuous, or research staff walked behind the patient with the oxygen source (not recommended). Measurements of pulse and SpO2 should be made after waiting at least 10 minutes after any change in oxygen delivery. Medications The type of medication, dose, and number of hours taken before the test should be noted. INTERPRETATION A 6MWT will be completed before the study-related cardiac MRI at the 6-Month Visit. The 6MWT measurements after aortic valve replacement surgery will be used to determine whether the patient has experienced a clinically significant improvement. Conclusions The 6MWT is a useful measure of functional capacity targeted at people with at least moderately severe impairment. The test has been widely used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease. These guidelines provide a standardized approach to performing the 6MWT. The committee hopes that these guidelines will encourage further research into the 6MWT and allow direct comparisons among different studies. To download the 6MWT Worksheet and access the electronic case report forms for inputting data related to this procedure, go to www.acrin.org/4008_protocol.aspx and click on “Data Forms” to the left of the computer screen. Reference: ATS Statement: Guidelines for the Six-Minute Walk Test. Am J Respir Crit Care Med. 2002;166(1):111–117. Available online at: http://ajrccm.atsjournals.org/content/166/1/111. Accessed January 18, 2012. ACRIN PA 4008 16 October 31, 2012 APPENDIX IV: KANSAS CITY CARDIOMYOPATHY QUESTIONNAIRE ACRIN PA 4008 The following questions refer to your heart failure and how it may affect your life. Please read and complete the following questions. There are no right or wrong answers. Please mark the answer that best applies to you. 1. Heart failure affects different people in different ways. Some feel shortness of breath while others feel fatigue. Please indicate how much you are limited by heart failure (shortness of breath or fatigue) in your ability to do the following activities over the past 2 weeks. Place an X in one box on each line Activity Extremely Limited Quite a bit Limited Dressing yourself ❏ ❏ ❏ ❏ ❏ ❏ Showering/Bathing ❏ ❏ ❏ ❏ ❏ ❏ Walking 1 block on level ground ❏ ❏ ❏ ❏ ❏ ❏ Doing yardwork, housework or carrying groceries ❏ ❏ ❏ ❏ ❏ ❏ Climbing a flight of stairs without stopping ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ ❏ Hurrying or jogging (as if to catch a bus) 2. 3. 4. Moderately Limited Slightly Limited Not at all Limited Limited for other reasons or did not do the activity Compared with 2 weeks ago, have your symptoms of heart failure (shortness of breath, fatigue or ankle swelling) changed? My symptoms of heart failure have become... Much worse Slightly worse Not changed Slightly better Much better I’ve had no symptoms over the last 2 weeks ❏ ❏ ❏ ❏ ❏ ❏ Over the past 2 weeks, how many times did you have swelling in your feet, ankles or legs when you woke up in the morning? Every morning 3 or more times a week, but not every day 1-2 times a week Less than once a week Never over the past 2 weeks ❏ ❏ ❏ ❏ ❏ Over the past 2 weeks, how much has swelling in your feet, ankles or legs bothered you? It has been... Extremely bothersome Quite a bit bothersome Moderately bothersome Slightly bothersome Not at all bothersome I’ve had no swelling ❏ ❏ ❏ ❏ ❏ ❏ ACRIN PA 4008 17 October 31, 2012 5. 6. 7. 8. 9. Over the past 2 weeks, on average, how many times has fatigue limited your ability to do what you want? All of the time Several times per day At least once a day 3 or more times a week but not every day 1-2 times a week Less than once a week Never over the past 2 weeks ❏ ❏ ❏ ❏ ❏ ❏ ❏ Over the past 2 weeks, how much has your fatigue bothered you? It has been... Extremely bothersome Quite a bit bothersome Moderately bothersome Slightly bothersome Not at all bothersome I’ve had no fatigue ❏ ❏ ❏ ❏ ❏ ❏ Over the past 2 weeks, on average, how many times has shortness of breath limited your ability to do what you wanted? All of the time Several times per day At least once a day 3 or more times a week but not every day 1-2 times a week Less than once a week Never over the past 2 weeks ❏ ❏ ❏ ❏ ❏ ❏ ❏ Over the past 2 weeks, how much has your shortness of breath bothered you? It has been... Extremely bothersome Quite a bit bothersome Moderately bothersome Slightly bothersome Not at all bothersome I’ve had no shortness of breath ❏ ❏ ❏ ❏ ❏ ❏ Over the past 2 weeks, on average, how many times have you been forced to sleep sitting up in a chair or with at least 3 pillows to prop you up because of shortness of breath? Every night 3 or more times a week but not every day 1-2 times a week Less than once a week Never over the past 2 weeks ❏ ❏ ❏ ❏ ❏ 10. Heart failure symptoms can worsen for a number of reasons. How sure are you that you know what to do, or whom to call, if your heart failure gets worse? Not at all sure Not very sure Somewhat sure Mostly sure Completely sure ❏ ❏ ❏ ❏ ❏ 11. How well do you understand what things you are able to do to keep your heart failure symptoms from getting worse? (for example, weighing yourself, eating a low salt diet, etc.) Do not understand at all Do not understand very well Somewhat understand Mostly understand Completely understand ❏ ❏ ❏ ❏ ❏ 12. Over the past 2 weeks, how much has your heart failure limited your enjoyment of life? It has extremely limited my enjoyment of life It has limited my enjoyment of life quite a bit It has moderately limited my enjoyment of life It has slightly limited my enjoyment of life It has not limited my enjoyment of life at all ❏ ❏ ❏ ❏ ❏ ACRIN PA 4008 18 October 31, 2012 13. If you had to spend the rest of your life with your heart failure the way it is right now, how would you feel about this? Not at all satisfied Mostly dissatisfied Somewhat dissatisfied Mostly satisfied Completely satisfied ❏ ❏ ❏ ❏ ❏ 14. Over the past 2 weeks, how often have you felt discouraged or down in the dumps because of your heart failure? I felt that way all of the time I felt that way most of the time I occasionally felt that way I rarely felt that way I never felt that way ❏ ❏ ❏ ❏ ❏ 15. How much does your heart failure affect your lifestyle? Please indicate how your heart failure may have limited your participation in the following activities over the past 2 weeks. Please place an X in one box on each line Severely limited Limited quite a bit Moderately limited Slightly limited Did not limit at all Does not apply or did not do for other reason Hobbies, recreational activities ❏ ❏ ❏ ❏ ❏ ❏ Working or doing household chores ❏ ❏ ❏ ❏ ❏ ❏ Visiting family or friends out of your home ❏ ❏ ❏ ❏ ❏ ❏ Intimate relationship with loved ones ❏ ❏ ❏ ❏ ❏ ❏ Activity ACRIN PA 4008 19 October 31, 2012