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AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK
ACRIN PA 4008
INFORMED CONSENT FORM TEMPLATE
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 trial, a type of research study. Research staff will explain the clinical trial to you.
Clinical trials 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 trial you must be willing to have two magnetic resonance imaging (MRI) scans of your heart
and agreed to have your heart and kidneys checked beforehand to ensure joining the trial is safe for you.
The cardiac MRI scans 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 cardiac MRI technology to measure the framework of
your heart before and after 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 your
treating doctor and 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 trial 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.
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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.
About MRI Scans
You will have an MRI scan of your heart to look for heart disease that may require 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 in the future about studies that are related to what is found during this study. 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 trials.
This trial 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.
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.
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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 28 days before you join the trial.
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 trial, you are being asked to
have two (2) heart MRI studies, one within a few weeks (21 days) 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”).
Cardiac MRI scans will be done in an 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 if 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 us to see the heart better. Gadolinium is approved by the FDA and is commonly
used with MRI scans in patients with no kidney disease. 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 10 to
15 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. 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 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.
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
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 will 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 blood left over from the tests of circulating biomarkers for this study will be kept for
a maximum of five (5) years and will be used only to test new biomarkers found during
that timeline so the results can be compared with all of the data from this study.

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 cardiac health.
All your information will be handled confidentially as per your Institutional and protocol
standards.

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.

Two (2) separate 6-minute walk tests.
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 test twice (in the baseline visit
before your valve replacement surgery and 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.
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STUDY CHART
VISIT 1: Eligibility and Registration






VISIT 2: CARDIAC MRI SCAN 1
*Within the 3 Weeks (21 Days)
Before Aortic Valve Replacement
Surgery*
Read and sign this informed consent form (ICF).
Have a medical history assessment, including reviewing
your heart health history, tests to rule out coronary artery
disease, and making 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).
Have a pregnancy test, if applicable.
Have your first cardiac MRI scheduled for within the next
three (3) weeks (21 days).
On the first study visit, within 21 days before your surgery,
you will:

Have an intravenous (IV) line placed in your arm to
introduce the contrast agent.

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.
On the second study visit, about six (6) months after your
heart surgery, you will:
VISIT 3: CARDIAC MRI SCAN 2
*About Six (6) Months After Aortic
Valve Replacement Surgery*
ACRIN PA 4008

Have a medical history assessment.

Complete a quality-of-life questionnaire
(short, about 5 minutes).

Have an IV line placed in your arm to introduce the
contrast agent.

Have about three (3) vials (15 to 30 mL) of blood taken.

Have a gadolinium-enhanced 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.
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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. Other drugs will 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 risks that that will occasionally occur in 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.
 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 study-related
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 involved in 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.
 MRIs will be done with a contrast agent called gadolinium, which allows the study
doctors to measure of tissue scarring. Gadolinium is approved by the FDA and is
commonly used with MRI procedures in patients with no kidney disease. Some
patients with severely reduced kidney function have been injured by gadolinium
(developed a potentially fatal skin disease called nephrogenic systemic fibrosis [NSF]).
 Psychological risks are very unlikely in this study.
 The 6-Minute Walk Test could result in cardiovascular collapse. Although extremely
unlikely 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.
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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 cardiac MRI on the fetus, breast-feeding baby, or mother-to-be, and this study may
cause harm. Because the gadolinium used in this study can 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 does become
pregnant, you will need to tell your study doctor immediately.
Ask your study doctor about counseling and more information about preventing pregnancy.
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 MRI or PET scans)
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
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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 trial 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 heart MRIs 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 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 trial conduct allows reasonable reimbursement for travel expenses and time away from work
associated with trial 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.
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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.
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
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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.>>
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