Status:
COMPLETED
REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Acute ST Elevation Myocardial Infarction
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.
Detailed Description
REVEAL is a randomized, double-blinded, placebo-controlled, parallel phase II clinical study that will evaluate the effects of erythropoietin administration on infarct size, left ventricular remodelin...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than 21 years
- Acute ST-elevation myocardial infarction
- Referral for primary or rescue angioplasty
- Revascularization procedure within 8 hours from the onset of ischemic symptoms
- TIMI (Thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary artery at the beginning of coronary angiography
- Successful revascularization of infarct-related artery
- EXCLUSION CRITERIA:
- Clinical indication for erythropoietin
- STEMI (ST-elevation myocardial infarction) due to occlusion of a branch vessel
- Any history of prior MI, PCI (Percutaneous coronary intervention), CABG (Coronary artery bypass graft), cardiomyopathy, myocarditis, or CHF (congestive heart failure)
- Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin
- Hematocrit greater than 42% in men or greater than 40% in women at the time of study drug administration
- Uncontrolled hypertension at the time of study drug administration
- Cardiogenic shock
- Need for coronary surgical revascularization as determined at the time of the index coronary catheterization
- History of hypercoagulable disorder, thromboembolic event, or venous thrombosis
- History of stroke or TIA (transient ischemic attack)
- History of seizures
- Contraindication to MRI
- Pregnancy or nursing mother
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00378352
Start Date
September 1 2005
End Date
January 1 2011
Last Update
May 9 2017
Active Locations (16)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
University of Miami, School of Medicine
Miami, Florida, United States, 33136
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Henry Ford Hospital
Detroit, Michigan, United States, 48202