Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack
|First Received Date ICMJE||December 13, 2004|
|Last Updated Date||January 31, 2013|
|Start Date ICMJE||January 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00099411 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack|
|Official Title ICMJE||Myocardial Viability and Remodeling in the Occluded Artery Trial (OAT)-Ancillary to OAT|
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).
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
People who have experienced a heart attack 3 to 28 days prior to study entry.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||200|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00099411|
|Other Study ID Numbers ICMJE||1279, R01HL075456, R01 HL75456|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Tufts Medical Center|
|Study Sponsor ICMJE||Tufts Medical Center|
|Collaborators ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Information Provided By||Tufts Medical Center|
|Verification Date||January 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP