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Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00099411
First received: December 13, 2004
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to assess the effect of heart muscle viability on left ventricular (LV) remodeling after a heart attack; to explore the relationships between retained viability of the area of tissue death (infarct zone), LV remodeling, response to the Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary intervention of the infarct related artery (IRA).


Condition
Cardiovascular Diseases
Coronary Disease
Myocardial Infarction
Heart Diseases
Heart Failure, Congestive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocardial Viability and Remodeling in the Occluded Artery Trial (OAT)-Ancillary to OAT

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Estimated Enrollment: 200
Study Start Date: January 2004
Detailed Description:

BACKGROUND:

Coronary heart disease is a major health problem in the United States. It is estimated that in 2003, more than 600,000 Americans had a new heart attack, and more than 400,000 experienced a recurrent heart attack. Up to 40% of individuals with a new or recurrent heart attack will show a complete occlusion, or blocking, of the IRA on follow-up angiography. Many people with an occluded IRA post-heart attack are at risk for progressive LV remodeling in the heart, which can lead to congestive heart failure.

The NHLBI-funded OAT study is testing the hypothesis that opening an occluded IRA 3 to 28 days following a heart attack will reduce the composite endpoint of mortality, recurrent heart attack, and New York Heart Association class IV heart failure over a three-year follow-up period. OAT has enrolled approximately 1,100 participants at 240 centers in 24 countries. Among the mechanisms proposed to explain the benefit of late revascularization, recovery of LV function and attenuation of LV remodeling due to restoration of blood flow to viable myocardium, or heart muscle, is the most plausible.

DESIGN NARRATIVE:

An estimated 200 individuals who have had a heart attack will be enrolled in this study. The primary aims of this study are the following: 1) to test the hypothesis that participants who demonstrate preservation of viability within the infarct zone will have less progressive remodeling compared to participants exhibiting predominant infarct, and 2) to test the hypothesis that preservation of viability will modify the treatment effect of randomization to late revascularization in participants with an occluded IRA 3 to 28 days after the heart attack. All participants will have resting gated Tc-99m sestamibi SPECT imaging at baseline, and again 1 year later. Parameters of baseline viability within the infarct zone, and serial measures of LV volume change and function will be centrally assessed by the Cardiac Imaging Core Laboratory at Tufts Medical Center. The major study endpoint to address the hypotheses will be serial change in LV end-diastolic volume, based on the degree of preservation of viability within the defined infarct zone. Sample size calculations will be based on data evaluated by the same group from a similar number of participants studied at a similar number of clinical sites.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People who have experienced a heart attack 3 to 28 days prior to study entry.

Criteria

Inclusion Criteria:

  • Has experienced a heart attack 3 to 28 days prior to study entry
  • Has an occluded IRA at catheterization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099411

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 10010
Sponsors and Collaborators
Tufts Medical Center
Investigators
Study Chair: James E. Udelson Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00099411     History of Changes
Other Study ID Numbers: 1279, R01HL075456, R01 HL75456
Study First Received: December 13, 2004
Last Updated: January 31, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Heart Failure
Infarction
Myocardial Infarction
Arterial Occlusive Diseases
Arteriosclerosis
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014