The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction

This study has been completed.

First Received: April 15, 2009 Last Updated: April 16, 2009 History of Changes

Sponsored by:	Seoul National University Bundang Hospital
Information provided by:	Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:	NCT00882466

Purpose

The purpose of this study is to investigate the effect of intravenous human recombinant erythropoietin on the reperfusion injury at primary percutaneous coronary intervention in patients with acute myocardial infarction.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: human recombinant erythropoietin	Phase IV

MedlinePlus related topics: Heart Attack

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:

Creatinine kinase (CK), creatinine kinase-MB (CK-MB) [ Time Frame: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Infarct size assessed by cardiac MRI [ Time Frame: day 4 ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	May 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PCI only: No Intervention primary PCI only
EPO: Experimental	Drug: human recombinant erythropoietin intravenous bolus injection of EPO (50unit/kg)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute myocardial infarction <12hr
Age >18yrs
First myocardial infarction
culprit lesion : proximal to mid left anterior descending artery
Baseline coronary flow : TIMI Grade 0~1

Exclusion Criteria:

Patients with previous myocardial infarction
History of thrombotic complication
History of cerebral infarction
Uncontrolled hypertension
Increased hemoglobin level >17g/dL
Patients with mechanical valve
Cardiogenic shock

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882466

Locations

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

Principal Investigator:

Dong-Ju Choi, MD,PhD

Seoul National University Bundang Hospital

More Information

No publications provided

Responsible Party:	Seoul National University Bundang Hospital ( Dong-Ju Choi )
Study ID Numbers:	EPO in AMI
Study First Received:	April 15, 2009
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00882466 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:

erythropoietin

Study placed in the following topic categories:

Epoetin Alfa
Necrosis
Heart Diseases
Hematinics
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Epoetin Alfa
Heart Diseases
Hematinics
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Ischemia

Pharmacologic Actions
Necrosis
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009