MedDataX Logo

Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction

NCT ID: NCT00333320

Last Updated: 2012-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

acute myocardial infarction postconditioning coronary reserve ejection fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

- Control

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type PROCEDURE

Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.

-postconditioning group

Group Type EXPERIMENTAL

postconditioning

Intervention Type PROCEDURE

patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

postconditioning

patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion

Intervention Type PROCEDURE

Control group

Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philippe Le Corvoisier, MD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Henri Mondor University Hospital

Créteil, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SFC-2006-02

Identifier Type: -

Identifier Source: secondary_id

POSTCONDITIONING

Identifier Type: -

Identifier Source: org_study_id