Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 19 - 75 |
| Updated: | 5/5/2014 |
| Start Date: | July 2010 |
| End Date: | July 2012 |
| Contact: | Christina Vassileva, M.D. |
| Email: | cvassileva@siumed.edu |
| Phone: | 217-545-7698 |
Medical Versus Surgical Management of Patients With Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention for Myocardial Infarction: A Pilot Prospective Randomized Trial
The pilot prospective randomized trial is designed to determine the safety and feasibility
of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following
Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing
medical management of MR. The investigators hypothesize that if moderate MR is corrected in
this patient subset, the patients will have improved outcomes as measured by decreased
number of major adverse cardiac events, including death, congestive heart failure requiring
hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA)
functional status and improved quality of life.
of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following
Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing
medical management of MR. The investigators hypothesize that if moderate MR is corrected in
this patient subset, the patients will have improved outcomes as measured by decreased
number of major adverse cardiac events, including death, congestive heart failure requiring
hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA)
functional status and improved quality of life.
Mitral regurgitation (MR) is a frequent complication of myocardial infarction. Ischemic MR
portends a poor prognosis on long term follow up. This pilot prospective randomized trial is
a safety and feasibility trial to evaluate mitral valve repair versus surgical management in
patients with residual MR after primary percutaneous coronary intervention (PCI). Patients
will be screened for possible inclusion to identify those that have first MI treated with
primary PCI. Patients with moderate MR at 6 or more weeks following first primary PCI will
be randomized to continued medical management versus surgical mitral valve repair. Patients
with previous or subsequent coronary artery bypass surgery and patients with severe
ventricular dysfunction will be excluded. Patients will be followed for one year from the
time of randomization. The safety and feasibility data will be used to design a large trial
powered to detect a difference in mortality between treatment arms.
Results of this study could lead to a radical change in the treatment paradigm for patients
with ischemic MR following PCI for acute MI. In addition, insight gained from this study
could advance our understanding of the interrelationship between LV remodeling and MR and
shed some light into the mechanism of ventricular function deterioration following MI.
Moreover, it may provide a framework for the development of further recommendations with
respect to the indications for surgical intervention in this patient population.
portends a poor prognosis on long term follow up. This pilot prospective randomized trial is
a safety and feasibility trial to evaluate mitral valve repair versus surgical management in
patients with residual MR after primary percutaneous coronary intervention (PCI). Patients
will be screened for possible inclusion to identify those that have first MI treated with
primary PCI. Patients with moderate MR at 6 or more weeks following first primary PCI will
be randomized to continued medical management versus surgical mitral valve repair. Patients
with previous or subsequent coronary artery bypass surgery and patients with severe
ventricular dysfunction will be excluded. Patients will be followed for one year from the
time of randomization. The safety and feasibility data will be used to design a large trial
powered to detect a difference in mortality between treatment arms.
Results of this study could lead to a radical change in the treatment paradigm for patients
with ischemic MR following PCI for acute MI. In addition, insight gained from this study
could advance our understanding of the interrelationship between LV remodeling and MR and
shed some light into the mechanism of ventricular function deterioration following MI.
Moreover, it may provide a framework for the development of further recommendations with
respect to the indications for surgical intervention in this patient population.
Inclusion Criteria:
- Patients who have undergone PCI for first acute MI (index MI) since 7/1/09 at MMC and
STJ
- documented moderate mitral regurgitation on follow up echocardiography six or more
weeks after PCI procedure
- English speaking
Exclusion Criteria:
- CABG after PCI for acute MI
- History of previous MI prior to index MI
- History of previous PCI or CABG prior to index PCI
- EF <30 % on the echocardiogram at 6 weeks after PCI for MI
We found this trial at
1
site
801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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