Download ACRIN PA 4008 Amend 1

INFORMED CONSENT TEMPLATE
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.
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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.
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.
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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.
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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
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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



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.
VISIT 2: CARDIAC MRI SCAN 1 
*Within the 3 Weeks (21 Days)
Before Aortic Valve Replacement
Surgery*
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.
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
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
(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.
VISIT 3: CARDIAC MRI SCAN 2 
*About Six (6) Months After Aortic
Valve Replacement Surgery*
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.
questionnaire
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.
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



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.
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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
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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.
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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.>>
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