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Impact of Medical and Surgical Therapy on Functional Mitral Regurgitation
This study has been completed.
First Received: September 21, 2005   Last Updated: December 11, 2007   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00224809
  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: Prevention, Randomized, Factorial Assignment
Official Title: Functional Mitral Regurgitation in STICH

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224809

Locations
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Investigators
Study Chair: Paul A. Grayburn Baylor Research Institute
  More Information

No publications provided

Study ID Numbers: 266, R01 HL72430
Study First Received: September 21, 2005
Last Updated: December 11, 2007
ClinicalTrials.gov Identifier: NCT00224809     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Diseases
Hormone Antagonists
Myocardial Ischemia
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Cardiovascular Agents
Ischemia
Arteriosclerosis
Hormones
Protease Inhibitors
Spironolactone
Heart Valve Diseases
Coronary Disease
Aldosterone Antagonists
Aspirin
Clopidogrel
Angiotensin-Converting Enzyme Inhibitors
Platelet Aggregation Inhibitors
Coronary Artery Disease
Mitral Valve Insufficiency

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Hormone Antagonists
Hematologic Agents
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Arteriosclerosis
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Arterial Occlusive Diseases
Heart Diseases
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Spironolactone
Heart Valve Diseases
Protease Inhibitors
Coronary Disease
Aldosterone Antagonists
Natriuretic Agents
Clopidogrel
Platelet Aggregation Inhibitors
Coronary Artery Disease
Mitral Valve Insufficiency

ClinicalTrials.gov processed this record on July 02, 2009