Status:
COMPLETED
Impact of Medical and Surgical Therapy on Functional Mitral Regurgitation
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
BACKGROUND: Functional MR is a common complication of ischemic heart disease. Two large studies have confirmed an adverse effect of functional MR on survival after a heart attack. However, studies in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00224809
Start Date
September 1 2002
End Date
May 1 2007
Last Update
February 19 2014
Active Locations (1)
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1
Baylor Research Institute
Dallas, Texas, United States, 75204