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

April 16, 2009 updated by: Seoul National University Bundang Hospital

Phase 4 Study of the Effect of Human Recombinant Erythropoietin at the Time of Reperfusion in Patients With Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: PCI only
primary PCI only
EXPERIMENTAL: EPO
Drug: human recombinant erythropoietin
intravenous bolus injection of EPO (50unit/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creatinine kinase (CK), creatinine kinase-MB (CK-MB)
Time Frame: 4hr, 8hr, 12hr, 24hr, 48hr, 72hr
4hr, 8hr, 12hr, 24hr, 48hr, 72hr

Secondary Outcome Measures

Outcome Measure
Time Frame
Infarct size assessed by cardiac MRI
Time Frame: day 4
day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (ESTIMATE)

April 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPO in AMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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