The Effect of Erythropoietin at the Time of Reperfusion i... | NCT00882466

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

NCT00882466

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Apr 17, 2009Estimated

Enrollment

58Actual

Phase

Phase 4

Conditions

Acute Myocardial Infarction

Interventions

human recombinant erythropoietin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Apr 15, 2009

First Submission Date that Met QC Criteria

Apr 15, 2009

First Posted Date

Apr 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2009

Last Update Posted Date

Apr 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCI only	No Intervention	primary PCI only
EPO	Experimental		Drug: human recombinant erythropoietin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
human recombinant erythropoietin	Drug	intravenous bolus injection of EPO (50unit/kg)	EPO

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Infarct size assessed by cardiac MRI		day 4

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong-Ju Choi, MD,PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam		463-707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20199815	Derived	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.