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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
human recombinant erythropoietin
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring erythropoietin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

PCI only

EPO

Arm Description

primary PCI only

Outcomes

Primary Outcome Measures

Creatinine kinase (CK), creatinine kinase-MB (CK-MB)

Secondary Outcome Measures

Infarct size assessed by cardiac MRI

Full Information

First Posted
April 15, 2009
Last Updated
April 16, 2009
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00882466
Brief Title
The Effect of Erythropoietin at the Time of Reperfusion in Acute Myocardial Infarction
Official Title
Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
erythropoietin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCI only
Arm Type
No Intervention
Arm Description
primary PCI only
Arm Title
EPO
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
human recombinant erythropoietin
Intervention Description
intravenous bolus injection of EPO (50unit/kg)
Primary Outcome Measure Information:
Title
Creatinine kinase (CK), creatinine kinase-MB (CK-MB)
Time Frame
4hr, 8hr, 12hr, 24hr, 48hr, 72hr
Secondary Outcome Measure Information:
Title
Infarct size assessed by cardiac MRI
Time Frame
day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD,PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20199815
Citation
Suh JW, Chung WY, Kim YS, Kim KI, Jeon EJ, Cho YS, Youn TJ, Chae IH, Kim CH, Choi DJ. The effect of intravenous administration of erythropoietin on the infarct size in primary percutaneous coronary intervention. Int J Cardiol. 2011 Jun 2;149(2):216-220. doi: 10.1016/j.ijcard.2010.02.002. Epub 2010 Mar 2.
Results Reference
derived

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

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