Impact of Medical and Surgical Therapy on Functional Mitral Regurgitation

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The Transesophageal Echocardiography (TEE) Surgical Treatment of Ischemic Heart Failure (STICH) ancillary study will define the mechanism(s) of functional mitral regurgitation (MR) by TEE in patients with ischemic cardiomyopathy, and the impact of therapy (medical, coronary artery bypass grafting [CABG], or CABG plus surgical ventricular restoration [SVR]) on mechanism and severity of MR. Severity of the effect of functional MR on clinical outcomes will also be examined. The TEE STICH study will address four specific aims that will focus on defining the following: 1) the mechanism(s) of functional MR in ischemic cardiomyopathy; 2) the effect of therapy on the mechanism and severity of functional MR; 3) myocardial viability on functional MR and its response to treatment; and 4) the effect of MR on prognosis in ischemic cardiomyopathy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Aspirin; Clopidogrel; Enzyme Inhibitors; Spironolactone

Criteria

Inclusion Criteria:

• LVEF less than .35, as measured by CMR ventriculogram, gated SPECT ventriculogram, echocardiography, or contrast ventriculogram within 3 months of study entry

• Has CAD suitable for revascularization

• Absence of left main CAD, as defined by an intraluminal stenosis of 50% or greater (to be eligible for MED Therapy)

• Absence of Canadian Class III angina or greater (angina markedly limiting ordinary activity) (to be eligible for MED Therapy)

• Dominant akinesia or dyskinesia of the anterior left ventricular wall amenable to SVR (to be eligible for SVR)

Exclusion Criteria:

• Aortic valvular heart disease clearly indicating the need for aortic valve repair or replacement

• Cardiogenic shock (within 72 hours of study entry), as defined by the need for intra-aortic balloon support or the requirement for intravenous inotropic support

• Plan for percutaneous intervention of CAD

• Recent acute myocardial infarction judged to be an important cause of left ventricular dysfunction

• History of more than one prior coronary bypass operation

• Non-cardiac illness with a life expectancy of less than 3 years

• Non-cardiac illness imposing substantial operative mortality

• Conditions or circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed address)

• Previous heart, kidney, liver, or lung transplantation

• Current participation in another investigational drug or investigational medical device study

• Women of childbearing potential