NCT00882466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

9 months

First QC Date

April 15, 2009

Last Update Submit

April 16, 2009

Conditions

Acute Myocardial Infarction

Keywords

erythropoietin

Outcome Measures

Primary Outcomes (1)

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

    4hr, 8hr, 12hr, 24hr, 48hr, 72hr

Secondary Outcomes (1)

  • Infarct size assessed by cardiac MRI

    day 4

Study Arms (2)

PCI only

NO INTERVENTION

primary PCI only

EPO

EXPERIMENTAL
Drug: human recombinant erythropoietin

Interventions

human recombinant erythropoietinDRUG

intravenous bolus injection of EPO (50unit/kg)

EPO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 20199815DERIVED

Study Officials

  • Dong-Ju Choi, MD,PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

May 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

KR(1)