Myocardial Infarction
Conditions
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.
Interventions
PROCEDUREControl
Deflated blood pressure cuff placed on upper arm for 30min
PROCEDURERIPer
Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total.
PROCEDURERIPer + IPost
Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total.
Sponsors
Fédération Française de Cardiologie
Société Française de Cardiologie
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size | 3 months | Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microvascular obstruction | 5 days | Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up |
| Left ventricular remodeling | 3 months | Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up |
Countries
France
Outcome results
None listed