Delayed Postconditioning

Phase 2

Completed

• Conditions: Myocardial Reperfusion Injury
• Interventions: Procedure: Percutaneaous intervention; Procedure: Postconditioning

• Registration Number: NCT01483755
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography.

Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade \> 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-26
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patient > 18 years old
• Male or female
• Presenting first myocardial infarction, with the beginning of pains < 12 hours,
• Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on LAD or RCA (not Circumflex coronary artery).
• TIMI flow grade at admission of 2 or 3
• LV angiography (RAO30°) before angioplasty.

Exclusion Criteria

• Cardiac arrest before the angioplasty
• Cardiogenic shock
• Occlusion of the artery circumflex responsible for the infarction
• Visible collaterals to the area at risk
• Magnetic resonance imaging: contra indication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional intervention	Percutaneaous intervention	36 control patients with conventional primary percutaneaous intervention (PCI)
Postconditionned	Postconditioning	36 postconditionned patients

Primary Outcome Measures

Name	Time	Method
Size of the infarct	Day 5 post reperfusion	Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion

Secondary Outcome Measures

Name	Time	Method
Contractile functional recovery	6 months after reperfusion	Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.

Trial Locations

Locations (5)

Service de Cardiologie, Hôpital Rangueil; 🇫🇷 Toulouse, France

Service de Cardiologie, CHU d'Angers; 🇫🇷 Angers, France

Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel; 🇫🇷 Bron, France

Service de Cardiologie, Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier Cedex 5, France

Service de Cardiologie, Hôpital Emile Müller; 🇫🇷 Mulhouse, France