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Impact of Medical and Surgical Therapy on Functional Mitral Regurgitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00224809
First Posted: September 23, 2005
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Baylor Research Institute
  Purpose
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.

Condition Intervention
Cardiovascular Diseases Heart Diseases Coronary Disease Drug: Angiotensin-Converting Enzyme Inhibitors Procedure: Coronary Artery Bypass Graft Drug: Angiotensin Receptor Blockers Drug: Spironolactone Drug: Aspirin Drug: Clopidogrel Procedure: Surgical Ventricular Restoration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
Official Title: Functional Mitral Regurgitation in STICH

Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Long term survival
  • Cardiac hospitalization (measured at follow-up evaluations)

Secondary Outcome Measures:
  • Diastolic mitral annulus area
  • Percent of systolic annular contraction
  • Leaflet tenting area
  • Papillary muscle tethering distance
  • Papillary muscle separation distance
  • Primary chordal separation angle
  • EROA and VCW (measured at Year 2)
  • Death
  • Cardiac transplantation
  • AICD countershock
  • Hospitalization due to heart failure
  • Subsequent mitral valve repair or replacement (measured at follow-up evaluations)

Estimated Enrollment: 250
Study Start Date: September 2002
Study Completion Date: May 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224809


Locations
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Baylor Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Paul A. Grayburn Baylor Research Institute
  More Information

ClinicalTrials.gov Identifier: NCT00224809     History of Changes
Other Study ID Numbers: 266
R01HL072430 ( U.S. NIH Grant/Contract )
First Submitted: September 21, 2005
First Posted: September 23, 2005
Last Update Posted: February 19, 2014
Last Verified: December 2007

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Mitral Valve Insufficiency
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Heart Valve Diseases
Clopidogrel
Spironolactone
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Protease Inhibitors