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Mitral Regurgitation Following PCI for MI: A Prospective Cohort Study Using Serial 2D Transthoracic Echocardiography

IRB Number

10-027

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

After having a heart attack it is possible to develop a leaky mitral heart valve. This happens in 13-50% of patients who have a heart attack. There are currently no established guidelines for how patients are to be followed to determine if they have developed a leaky heart valve. The purpose of this study is to evaluate how your heart is working in the first year after your heart attack. We are particularly interested in determining if you have had heart valve damage after your heart attack. The heart valve most likely to be damaged is the mitral valve. Sometimes damage occurs early after the heart attack and then the heart recovers or the problem may persist. Other times the heart may appear okay shortly after the heart attack and then damage to the heart valve becomes evident weeks or months later. This study will: • 1) Determine how often the leaky heart valve occurs. • 2) Determine when the leaky valve is likely to occur in the first year after a heart attack. • 3) Identify factors that might predict worsening of the leaky valve. • 4) Compare how people that develop a leaky valve do with those that do not develop a leaky valve. • 5) Examine findings in the study that may predict how patients with a leaky valve do long term.

Who is eligible to participate?

You are being asked to take part in this study because you recently had a PCI (percutaneous coronary intervention a procedure to open a blocked blood vessel in your heart) after a myocardial infarction (heart attack).

What is involved?

If you choose to take part in the study: • Quality of life and health status questionnaires will be obtained within two weeks and at 3, 6, and 12 months. The questionnaires will take approximately 30 minutes to complete at each visit. • Echocardiography (ECHO) is a painless test that uses sound waves to obtain a picture of the heart. Electrodes will be placed on your chest to get a reading of the electrical activity of your heart during the ECHO. The ECHO is performed by placing some gel on your chest and moving the probe across your chest to create a picture based on sound waves. It will be performed within two weeks of your heart procedure that was recently performed and then at 3, 6, and 12 months depending on the findings of the initial echocardiogram. You will need these tests and procedures that are part of regular care but they are being done more often because you are in this study. If your healthcare provider has ordered any of these tests near the study visits then we will not repeat the test. We would just collect the results from the tests ordered for your regular healthcare.

How long is the study?

You will be in the study for one year.

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