Phase
Condition
Chest Pain
Coronary Artery Disease
Cardiac Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 limitof normal and CK-MB elevated above the upper limit of the laboratory normal) ortroponin 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 cardiacserum markers are elevated (2), any one of the following EKG findings satisfyinclusion criteria; new ST-T changes (ST elevation or depression), new leftbundle-branch block (LBBB), loss of R-wave voltage ≥50% in ≥2 related leads or deep Twave 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 leftanterior descending (proximal to the second major diagonal branch); large rightcoronary artery; or circumflex, if supplying large obtuse marginal, and part ofinferior wall (i.e., large dominant or co-dominant vessel).
Exclusion
Exclusion Criteria:
Age <18 y
Clinical indication for revascularization defined as follows: rest or low-thresholdangina after MI; severe inducible ischemia on low level exercise or pharmacologicalstress testing (ST decreased ≥2 mm or inability to complete stage 1 or achieve 3-4metabolic equivalents without angina, hypotension, or reversible perfusion defects inmultiple territories or decreased wall motion thickening in >2 segments onechocardiogram); 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 increasesrisk of radiographic contrast
Severe valvular disease
History of anaphylaxis to radiographic contrast
Infarct artery too small (reference segment diameter <2.5 mm), target segment withinor beyond extreme tortuosity (>90° angulation), or otherwise technically a poorcandidate for PCI
Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographicevidence of chronicity, e.g., presence of bridging collaterals)
NYHA classes III-IV CHF; patients may be treated for acute heart failure complicatingMI 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 therapyafter stent implantation
Qualifying IRA that has been grafted previously; patients with prior CABG may beenrolled if the IRA was not previously grafted
Dilated or hypertrophic cardiomyopathy
Study Design
Study Description
Connect with a study center
New York University School of Medicine
New York, New York 10010
United StatesSite Not Available
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