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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00882466
First Posted: April 16, 2009
Last Update Posted: April 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Bundang Hospital
  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
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

Resource links provided by NLM:


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 ]

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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: April 15, 2009
First Posted: April 16, 2009
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


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