Delayed Postconditioning (PRIME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01483755|
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : July 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Reperfusion Injury||Procedure: Postconditioning Procedure: Percutaneaous intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Delayed Angioplasty Postconditioning in STEMI Patients|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|