Occluded Artery Trial (OAT)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Adrenergic Agents; Adrenergic Antagonists; Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Platelet Aggregation Inhibitors

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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