Clinical trial NCT01483755: Delayed Postconditioning
Official title: Delayed Angioplasty Postconditioning in STEMI Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Reperfusion Injury
Keywords: Myocardial infarction
Postconditioning
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Size of the infarct
timeFrame: Day 5 post reperfusion
Secondary outcomes:
measure: Contractile functional recovery
timeFrame: 6 months after reperfusion
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de Cardiologie, CHU d'Angers
city: Bron
country: France
facility: Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel
city: Montpellier Cedex 5
country: France
facility: Service de Cardiologie, Hôpital Arnaud de Villeneuve
city: Mulhouse
country: France
facility: Service de Cardiologie, Hôpital Emile Müller
city: Toulouse
country: France
facility: Service de Cardiologie, Hôpital Rangueil
Study officials:
References:
citation: Roubille F, Mewton N, Elbaz M, Roth O, Prunier F, Cung TT, Piot C, Roncalli J, Rioufol G, Bonnefoy-Cudraz E, Wiedemann JY, Furber A, Jacquemin L, Willoteaux S, Abi-Khallil W, Sanchez I, Finet G, Sibellas F, Ranc S, Boussaha I, Croisille P, Ovize M. No post-conditioning in the human heart with thrombolysis in myocardial infarction flow 2-3 on admission. Eur Heart J. 2014 Jul 1;35(25):1675-82. doi: 10.1093/eurheartj/ehu054. Epub 2014 Feb 28.