Clinical trial NCT01156441: Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention
Official title: Medical Versus Surgical Management of Patients With Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention for Myocardial Infarction: A Pilot Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Myocardial Infarction
Mitral Regurgitation
Keywords: Myocardial Infarction
Mitral Regurgitation
Percutaneous Coronary Intervention
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: patient survival
timeFrame: baseline to 1 year
Secondary outcomes:
measure: congestive heart failure requiring hospitalization
timeFrame: baseline and 1 year
measure: mitral regurgitation grade
timeFrame: baseline and 1 year
measure: new atrial fibrillation
timeFrame: baseline, 3 months, 6 months and 1 year
measure: NYHA functional class
timeFrame: baseline, 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Christina Vassileva, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vassileva CM, Boley T, Markwell S, Hazelrigg S. Meta-analysis of short-term and long-term survival following repair versus replacement for ischemic mitral regurgitation. Eur J Cardiothorac Surg. 2011 Mar;39(3):295-303. doi: 10.1016/j.ejcts.2010.06.034. Epub 2010 Aug 19.