Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention

Southern Illinois University

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Mitral Regurgitation; Myocardial Infarction

Treatments: Procedure: surgical mitral valve repair w/ mitral valve annuloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01156441

VAS-SIU-10-003-1

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

surgical mitral valve repair

Experimental group

Description:

Non-invasive transesophageal echocardiography will be performed on all study volunteers to determine if the individual has mitral regurgitation and, if so, to what degree. Mitral valve repair will be performed with mitral valve annuloplasty via median sternotomy, utilizing cardiopulmonary bypass and moderate hypothermia.

Treatment:

Procedure: surgical mitral valve repair w/ mitral valve annuloplasty

control: medical management

No Intervention group

Description:

Clinical observation will be continued without surgery. Non-invasive transesophageal echocardiography will be performed on all study volunteers to determine if the individual has mitral regurgitation and, if so, to what degree.