Delayed Postconditioning (PRIME)
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.
|Myocardial Reperfusion Injury||Procedure: Postconditioning Procedure: Percutaneaous intervention||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Delayed Angioplasty Postconditioning in STEMI Patients|
- Size of the infarct [ Time Frame: Day 5 post reperfusion ]Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion
- Contractile functional recovery [ Time Frame: 6 months after reperfusion ]Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.
|Study Start Date:||July 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
36 postconditionned patients
Postconditioning consists of four cycles of one minute balloon inflation followed by one minute of balloon deflation, with the initial inflation being started within the first minute after reopening of the culprit coronary artery.
Sham Comparator: Conventional intervention
36 control patients with conventional primary percutaneaous intervention (PCI)
Procedure: Percutaneaous intervention
Conventional primary percutaneaous intervention
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483755
|Service de Cardiologie, CHU d'Angers|
|Angers, France, 49933|
|Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel|
|Bron, France, 69677|
|Service de Cardiologie, Hôpital Arnaud de Villeneuve|
|Montpellier Cedex 5, France, 34295|
|Service de Cardiologie, Hôpital Emile Müller|
|Mulhouse, France, 68051|
|Service de Cardiologie, Hôpital Rangueil|
|Toulouse, France, 31059|