Clinical trial NCT01390142: Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction
Official title: Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Fédération Française de Cardiologie
name: Société Française de Cardiologie
First posted: 2011-07-08
Enrollment: 60
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: RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

Detailed description: In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury.

The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* ST-Segment elevation myocardial infarction \<6h
* Written informed consent

Exclusion Criteria:

* Previous Q-wave myocardial infarction or previous coronary artery bypass graft
* Cardiogenic shock
* Cardiac arrest resuscitated before angioplasty
* Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small.
* TIMI 2 or 3 before angioplasty
* Collateral branches Rentrop \>1
* TIMI 0 or 1 flow grade after PCI
* Any contraindications to magnetic resonance imaging
* Allergy to gadolinium
* Patient refusal / patient not having provided written informed consent

Primary outcomes:
measure: Infarct size
timeFrame: 3 months
Secondary outcomes:
measure: Microvascular obstruction
timeFrame: 5 days
measure: Left ventricular remodeling
timeFrame: 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers - Service de Cardiologie
Study officials:
affiliation: University Hospital, Angers
name: Fabrice Prunier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: