STUDY TITLE: SURGICAL INTERVENTIONS FOR MODERATE ISCHEMIC MITRAL REGURGITATION
Current Status: Enrollment Complete
What is the purpose of this research?
The purpose of the research is to determine whether repairing a mitral valve with moderate leakage, at the time of planned coronary
artery bypass graft (CABG) surgery, will improve health outcomes of those who receive it compared to those who don't. There are no
new or “experimental“ procedures being tested in this study: both the CABG procedure and mitral valve repair procedure are well
established surgeries and are regularly performed together in patients who have severe mitral valve leakage. What is not known with
certainty, but what will be tested in this study, is whether patients with a smaller amount of leakage of the mitral valve (moderate
mitral regurgitation) would benefit from the repair in addition to the CABG. At this point, the medical community is split in their
opinion of this additional procedure and the aim of this research is to resolve this question.
Who can be in this study?
People who have coronary artery heart disease, requiring a CABG surgery, and have leakage (regurgitation) of the mitral valve may
take part in this research study. The study is being conducted in 10 major medical centers in the United States and Canada and the
plan is to enroll 300 patients in total.
Who cannot be in this study?
Some reasons a person may not be able to participate in this research study include: prior mitral valve intervention, advanced liver,
kidney, or heart disease, or having a heart attack within one week of study enrollment.
Why Repair the Valve in Patients with Moderate Mitral Leakage who undergo CABG Surgery?
We know that patients who never
had mitral valve leakage have better outcomes following CABG surgery than those with a moderate degree of mitral leakage, which
suggests that repairing the mitral valve could be beneficial. In addition, we know that mitral repair is effective in stopping
the leakage, that this effect is long lasting, and there have been significant improvements in the mitral valve repair procedure over time.
Why not Repair Moderate Mitral Regurgitation in Patients who undergo CABG Surgery?
We know that patients who have CABG surgery
alone, without mitral valve repair for moderate leakage, do well. About half the patients with this problem are now treated this way.
Treating with CABG surgery alone shortens the operation and allows the procedure to be done without opening the heart. In some patients,
the mitral valve leakage improves after CABG surgery alone and in many others the leakage remains, but results in no symptoms or other
medical problems. In fact, if you did not need to have CABG surgery, there would be no reason to have a procedure to repair your valve
for just moderate leakage.
Why is this study necessary?
The available evidence addressing this issue has not been obtained through planned experiments
such as this one, but rather from observations of the results of the two surgical approaches that are both widely recommended and
performed. These observations have produced conflicting results. Thus, we do not know whether or not mitral repair adds additional
benefit to the CABG procedure. A planned experiment, in which we would have a very high level of certainty about what approach would
be best, will ensure that all patients with your condition will get the best procedure.
What procedures will be followed?
Once you have agreed to participate in the study and signed an informed consent document,
the study will proceed in the following stages.
First you will be asked to perform several tests, including a cardiopulmonary exercise test, which measures your body's ability to use oxygen during exercise, and an echocardiogram, which will take an ultrasound (sound wave) picture of your heart. Because the echocardiogram is the standard of care for these surgical procedures, you would undergo this test regardless of whether or not you participate in the study. The amount of mitral valve leakage observed on your echocardiogram will determine whether or not you are eligible to participate in this study. If eligible to participate, we will schedule you for a physical exam, blood tests, neurocognitive tests and ask you to complete questionnaires about your past medical history, medication history, and quality of life.
Assignment to receiving either the mitral valve repair or not in addition to the planned CABG surgery will occur while you are in the operating room and will be made by a scientific process (which involves random assignment, much like a coin toss). A scientific process is used to help make sure that the patients assigned to the two treatment groups (CABG with and without mitral valve repair) are very similar. The chance that you will be selected to receive the mitral valve in addition to your planned CABG surgery is 50%. You will be notified about whether or not you underwent the mitral valve repair in addition to the planned CABG surgery after your surgery.
All participants will undergo standard general anesthesia for heart surgery and have an incision made to expose the heart. Coronary artery bypass grafting will be performed using standard surgical techniques using either an artery from the chest and or veins from the leg to bypass the clogged coronary arteries. Following coronary bypass, patients who are assigned to this procedure only will be taken to the intensive care unit for recovery. Those patients assigned to mitral valve repair will undergo a standard surgical mitral valve repair before leaving the operating room. This will involve opening the heart and sewing a surgical ring to the mitral valve to limit its opening and prevent leakage. The steps in performing each of the operations are standard of care and would be performed in the manner described here whether or not you were enrolled in the study. An optional part of this research is to collect blood, urine and tissue for future studies.
After the surgery, all patients, regardless of whether their valve was repaired or not, will be asked to return for an outpatient evaluation at 6, 12, and 24 months. These evaluations will consist of a medication history, a physical exam, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys. The echocardiogram is the only test that would be performed regardless of whether or not you are in the study. All data that is collected prior to, during, and after the surgery will then be sent to a data coordinating center at Mount Sinai School of Medicine for storage and analysis.
What are the possible risks of being in this study?
The research involves approved surgical procedures. The health risks for you are
the same whether you have these procedures as a participant in the research study or outside of the research study.
What are the possible benefits of being in this study?
You may or may not receive personal (direct) benefit from taking part in this
study. The results of this study should provide important information for the medical treatment for future patients with heart conditions similar
to yours.
How long will I be in the study?
If you choose to participate in the study, the expected time period during which you would be involved in the study would be two years. You will
be asked to return for an outpatient follow-up visit for a total of 3 times: at 6, 12, and 24 months after surgery. Each visit will take
approximately 2 hours, and during that time, you can expect to have a physical exam, a cardiopulmonary exercise test, answer a quality of life
survey, and have an ultrasound examination of your heart, called an echocardiogram. The echocardiogram will be performed regardless of your
participation in this study.
What are the costs to be in this study?
Taking part in this study will not involve additional costs to you. All study specific
tests will be paid for by the study sponsor. You and/or your insurance company will have to pay for any costs that are part of your regular
medical care. Anything not paid by your health insurance for your medical care will be billed directly to you for payment.
You will not receive any compensation for your participation in this research study. You may receive a fixed amount of travel reimbursement to cover local travel expenses for your participation in study follow-up visits.
Who is funding this research?
This research is being supported by a research grant from the following government programs:
• National Heart, Lung, and Blood Institute (NHLBI)
• National Institute of Neurological Disorders and Stroke (NINDS)
• Canadian Institutes of Health Research (CIHR)
For any additional questions, you may send an email to the Mount Sinai Coordinating Center:
• Ellen Moquete, RN, BSN, ellen.moquete@mountsinai.org, 212-659-9651 or
• Karen O'Sullivan, MPH, karen.o'sullivan@mountsinai.org, 212-659-9720
For more information about this study, please visit
http://clinicaltrials.gov/ct2/show/NCT00806988
GCO# 08-1078(3); Current annual IRB approval period: 10/16/18 - 10/9/19
Principal Investigator: Alan J. Moskowitz, MD
