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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00882466
First received: April 15, 2009
Last updated: April 16, 2009
Last verified: April 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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
No Intervention: PCI only
primary PCI only
Experimental: EPO 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 by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Seoul National University Bundang Hospital:
erythropoietin

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Vascular Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013