Impact of Medical and Surgical Therapy on Functional Mitral Regurgitation

NCT00224809 | Completed

• 2 other identifiers: 266R01HL072430
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiovascular Diseases; Heart Diseases; Coronary Disease

Outcome Measures

Primary Outcomes (2)

• Long term survival

• Cardiac hospitalization (measured at follow-up evaluations)

Secondary Outcomes (12)

• Diastolic mitral annulus area

• Percent of systolic annular contraction

• Leaflet tenting area

• Papillary muscle tethering distance

• Papillary muscle separation distance

Interventions

Angiotensin-Converting Enzyme Inhibitors DRUG

Coronary Artery Bypass Graft PROCEDURE

Angiotensin Receptor Blockers DRUG

Spironolactone DRUG

Aspirin DRUG

Clopidogrel DRUG

Surgical Ventricular Restoration PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Coronary Disease

Interventions

Angiotensin-Converting Enzyme Inhibitors; Coronary Artery Bypass; Angiotensin Receptor Antagonists; Spironolactone; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paul A. Grayburn

  Baylor Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: September 1, 2002
• Study Completion: May 1, 2007
• Last Updated: February 19, 2014

Record last verified: 2007-12

Locations

US (1)