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Home > "O" Clinical Trials Conditions > Occluded Artery Trial (OAT)  Occluded Artery Trial (OAT)
Occluded Artery Trial (OAT)
For Condition: Heart Failure, Congestive,Myocardial Infarction,Cardiovascular Diseases,Heart Diseases,Heart Failure
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over a three year follow-up.
Details: BACKGROUND: The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacologic strategies fail to achieve effective reperfusion in 30 percent or more of patients, and many patients with occluded infarct arteries do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible US acute MI patients. Hence a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12 - 24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity. DESIGN NARRATIVE: Multicenter, randomized, controlled. Patients at approximately 320 clinical sites in the United States and Canada are randomly allocated to two treatment arms over two years. One treatment consists of conventional medical management including aspirin, beta blockers, angiotensen converting enzyme (ACE) inhibitors, and risk factor modification. The other treatment consists of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. Clinical outcomes will be compared using an intention-to-treat analysis. The primary composite endpoint is mortality, recurrent myocardial infarction, and hospitalization for NYHA Class IV congestive heart failure over a three year follow-up. Individual components of the study composite primary endpoint will be compared in the two treatment arms, as will the medical costs of the two treatments and the health-related quality of life. The cost-effectiveness of percutaneous revascularization will be assessed in the study population.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Three to twenty-eight days after an acute myocardial infarction
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithHochman, , New York University School of Medicine
New York University School of Medicine *Recruiting*
New York City, New York, 10016-9196
United States
Recruiting Judith Hochman 212-263-6927
Additional Information:
Study ID Numbers: 130;
Study Start Date: September 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004562
Other Heart Diseases Studies:
1. Enoximone Plus Extended-Release Metoprolol Succinate in Subjects with Advanced Chronic Heart Failure
2. Effect of Behavioral Management on Quality of Life in Heart Failure
3. Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.
4. Epidemiology of Cardiotoxicity in Children with Cancer
5. Honolulu Heart Program
Related Studies:
Other Heart Diseases Clinical Trials
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Other New York City Clinical Trials
Occluded Artery Trial (OAT)
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