Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack
|ClinicalTrials.gov Identifier: NCT00099411|
Recruitment Status : Completed
First Posted : December 14, 2004
Last Update Posted : April 27, 2017
|Condition or disease|
|Cardiovascular Diseases Coronary Disease Myocardial Infarction Heart Diseases Heart Failure, Congestive|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||124 participants|
|Official Title:||Myocardial Viability and Remodeling in the Occluded Artery Trial (OAT)-Ancillary to OAT|
|Actual Study Start Date :||January 2004|
|Primary Completion Date :||June 30, 2007|
|Study Completion Date :||June 30, 2007|
- The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year. [ Time Frame: 1 year ]The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099411
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 10010|
|Study Chair:||James E. Udelson||Tufts Medical Center|