REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
Acute ST Elevation Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00378352 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epoetin alfa (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- National Institute on Aging (NIA)
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infarct Size in the Territory of the Infarct Related Artery |
10.6; 10.4 | — |
| SECONDARY Infarct Size in the Territory of the Infarct Related Artery |
10.6; 10.4 | — |
| SECONDARY LV Ejection Fraction |
48.2; 48.9; 52.5; 52.0 | — |
| SECONDARY LV Volume Indexed to BSA |
34.7; 32.6; 34.1; 32.0; 65.6; 63.4 | — |
| SECONDARY LV Mass Indexed to BSA |
74.2; 69.2; 67.3; 61.8 | — |
| SECONDARY Vital Signs |
129.7; 126.2; 118.7; 112.9; 114.3; 114.3 | — |
| SECONDARY Hemoglobin Levels |
13.8; 13.6; 13.4; 13.1; 13.3; 13.1 | — |
| SECONDARY Reticulocyte Counts |
1.4; 1.3; 1.6; 1.3; 1.8; 1.3 | — |
| SECONDARY Number of Participants With Clinical Events |
1; 0; 2; 0; 6; 0 | — |
Summary
Eligibility Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00378352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.