Positive Effect of Ischemic Postconditioning During Acute... | NCT00333320

Studies
Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction

NCT00333320

Sponsor

French Cardiology Society

Status

Completed

Last Update Posted

Oct 23, 2012Estimated

Enrollment

46Actual

Phase

Phase 1Phase 2

Conditions

Acute Myocardial Infarction

Interventions

postconditioning
Control group

Countries

France

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

ID	Type	Description	Link
SFC-2006-02

Status Module

Record Verification Date

Oct 2012

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

Sep 2006

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2011Actual

First Submitted Date

Jun 2, 2006

First Submission Date that Met QC Criteria

Jun 2, 2006

First Posted Date

Jun 5, 2006Estimated

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

Oct 22, 2012

Last Update Posted Date

Oct 23, 2012Estimated

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 determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans

Detailed Description

Desobstruction of the culprit artery after acute myocardial infarction allows to reduce the consequences of prolonged ischemia. However, it is now clearly established that reperfusion induces by itself severe myocardial injuries. Postconditioning has been described as an adaptive response triggered by a brief ischemia applied after a prolonged coronary occlusion. Several teams have reported that ischemia/reperfusion cycles allow to reduce infarct size in experimental models.

Different pathophysiological processes have been proposed to explain the beneficial effect of postconditioning. It has been reported that postconditioning reduces the inflammatory response, and activates cardioprotective signaling pathways (Akt, eNOS, p70S6K). In addition, an improvement of the endothelial function has been reported.

This controlled trial aim to study the potential beneficial effect of postconditioning in patients with acute myocardial infarction. Forty six patients will be included in the study and the culprit artery will be reoccluded three times for 1 minutes after desobstruction in one of the both groups after randomization of the patients.

The evaluation will be focused on the comparison of the coronary reserve after intracoronary adenosine injection. In addition, additional parameters will be used to study the effect of postconditioning on post-ischemic endothelial dysfunction: frequencies of low reflow and slow reflow situation, myocardial blush and regression of ST elevation. The effect of postconditioning on the left ventricular systolic function will be studied by Doppler tissue imaging and RMN.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
- Control	Placebo Comparator		Procedure: Control group
-postconditioning group	Experimental		Procedure: postconditioning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
postconditioning	Procedure	patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion	-postconditioning group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
coronary reserve after intracoronary adenosine injection		Immediately after the postconditioning procedure

Secondary Outcomes

Measure	Description	Time Frame
frequencies of low reflow and slow reflow situation		after postconditioning
regression of ST elevation		1h and 24h after postconditioning
left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute myocardial infarction (<6 hours)
Occlusion of a major coronary vessel

Exclusion Criteria:

History of previous myocardial infarction
History of Coronary Artery Bypass Grafting
Need for Coronary Artery Bypass Grafting
Stenosis not eligible for angioplasty
Limited ischemic area
Cardiogenic shock
Interventricular septum rupture
Mitral regurgitation>2
Ventricular tachycardia
Atrioventricular block class II and III

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
Philippe Le Corvoisier, MD	Henri Mondor University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henri Mondor University Hospital		Créteil		94010	France

Intervention Browse Module

MeSH Terms

ID	Term
D057775	Ischemic Postconditioning
D035061	Control Groups

Ancestor Terms

ID	Term
D013812	Therapeutics
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques

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