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

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ClinicalTrials.gov Identifier: NCT00882466
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : April 17, 2009
Sponsor:
Information provided by:
Seoul National University Bundang Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: human recombinant erythropoietin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

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

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



Primary Outcome Measures :
  1. Creatinine kinase (CK), creatinine kinase-MB (CK-MB) [ Time Frame: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr ]

Secondary Outcome Measures :
  1. Infarct size assessed by cardiac MRI [ Time Frame: day 4 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009

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