SIU School of Medicine

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Medical Versus Surgical Management of Patients with Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention for Myocardial Infarction

IRB Number

10-010

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

The purpose of this study is to compare the effects, good and/or bad, of medical treatment with surgery on you and your mitral valve (leaky heart valve) to find out which is better. In this study, you will get either the medical treatment only or the heart surgery plus medical treatment.

Who is eligible to participate?

Patients who have a leaky heart valve caused by earlier heart attack. This diagnosis is determined by an echocardiography test that patient had performed six or more weeks after heart attack.

What is involved?

To be in the study, patients will be “randomized” into one of the study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin or pulling numbers from a hat. Neither you nor the study doctor can choose what group you will be in. You will have an equal chance of being placed in either group. If you are in group 1 you will continue to receive medical treatment for your heart valve problem. We will obtain information from your medical records including your prior cardiac catheterization and ECHO results. We will call you at 2 weeks to check on how you are doing. In addition we will have follow up visits with you and review your medical records at 3 months. You will also complete 3 quality of life and illness questionnaires at your baseline and at 3 months visit and we will mail the questionnaires to you one month after baseline. If you are in group 2 you will have surgery to repair the leaky heart valve. We will obtain information from your medical records including your prior cardiac catheterization and ECHO results. We will record information about your surgical hospital stay. In addition we will have follow up visits with you and review your medical records at 2 weeks and 3 months. You will also complete 3 quality of life and illness questionnaires at baseline, 2 weeks and at 3 months.

How long is the study?

You will be in this study for 3-5 months.

Who can I contact for additional information?

Please contact Theresa Boley, RN, MSN, APN/FNP, CCRP at 217-545-5000 or email tboley@siumed.edu

Who is the Principal Investigator of this study?

Christina Vassileva, MD

Where is the trial located?

Springfield, Illinois