Occluded Artery Trial (OAT)
Condition: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Heart Failure, Congestive; Heart Failure
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Infarction
Intervention: Beta adrenergic blockers; Platelet inhibitors; PTCA and stents; ACE Inhibitors
Intervention description: Participants will receive beta adrenergic blockers.; Participants will receive platelet inhibitors.; Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.; Participants will receive ACE inhibitors.
Intervention MeSH terms: Platelet Aggregation Inhibitors; Adrenergic beta-Antagonists; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Adrenergic Agents; Adrenergic Antagonists
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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