Occluded Artery Trial (OAT)

Completed · Phase 3

Conditions studied: Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Heart Failure, Congestive, Heart Failure

In brief

The purpose of this study is 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 an average 2.9-year follow-up with extended follow up for an average of six years. Long term follow-up of patients were completed in March 2010. Final collection of all regulatory documentation was completed June 2011.

Key facts

Study ID

NCT00004562

Run by

NYU Langone Health

People needed

2201

Starts

1999-09-01

Expected to finish

2011-06-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recent MI (3-28 days) (Day 1 is the calendar day of the MI system onset)
• MI is defined based on at least 2 of 3 MI criteria confirmed by: 1) ischemic symptoms ≥30 minutes, 2) cardiac serum marker elevation (creatine kinase (CK) ≥2x upper limit of normal and CK-MB elevated above the upper limit of the laboratory normal) or troponin T, or troponin I elevated at least twice the upper limit of normal, 3) EKG: New Q-waves of ≥0.03 sec and/or 1/3 of QRS complex in ≥2 related EKG leads. If cardiac serum markers are elevated (2), any one of the following EKG findings satisfy inclusion criteria; new ST-T changes (ST elevation or depression), new left bundle-branch block (LBBB), loss of R-wave voltage ≥50% in ≥2 related leads or deep T wave inversions ≥3mm in ≥2 leads.
• TIMI flow 0 or 1 in infarct related artery (IRA)
• Meets criteria for high risk: EF <50% or site of occlusion is proximal, in left anterior descending (proximal to the second major diagonal branch); large right coronary artery; or circumflex, if supplying large obtuse marginal, and part of inferior wall (i.e., large dominant or co-dominant vessel).

You may not qualify if…

• Age <18 y
• Clinical indication for revascularization defined as follows: rest or low-threshold angina after MI; severe inducible ischemia on low level exercise or pharmacological stress testing (ST decreased ≥2 mm or inability to complete stage 1 or achieve 3-4 metabolic equivalents without angina, hypotension, or reversible perfusion defects in multiple territories or decreased wall motion thickening in >2 segments on echocardiogram); left main coronary disease (≥50% stenosis); or triple-vessel disease (3 major epicardial coronaries with >70% stenoses)
• Serious illness such as cancer or pulmonary disease that limits 3-year survival
• Severe renal disease defined as serum creatinine >3.0 mg/dL that markedly increases risk of radiographic contrast
• Severe valvular disease
• History of anaphylaxis to radiographic contrast
• Infarct artery too small (reference segment diameter <2.5 mm), target segment within or beyond extreme tortuosity (>90° angulation), or otherwise technically a poor candidate for PCI
• Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographic evidence of chronicity, e.g., presence of bridging collaterals)
• NYHA classes III-IV CHF; patients may be treated for acute heart failure complicating MI and rescreened
• Cardiogenic shock or sustained hypotension: systolic BP <90 mm Hg or cardiac index <2.2 L/min per m\^2
• LV aneurysm in the same location as index MI and present before index MI
• Inability to cooperate with the protocol
• Patient refusal or inability to give informed consent
• Refusal of patient's physician to allow patient to participate
• Pregnancy
• Contraindication to anticoagulation during PCI or to routine antiplatelet therapy after stent implantation
• Qualifying IRA that has been grafted previously; patients with prior CABG may be enrolled if the IRA was not previously grafted
• Dilated or hypertrophic cardiomyopathy

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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