Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction - Full Text View

Sponsor:	University Hospital, Angers
Collaborators:	Fédération Française de Cardiologie Société Française de Cardiologie
Information provided by:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT01390142

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction	Procedure: Control Procedure: RIPer Procedure: RIPer + IPost	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:

Infarct size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up

Secondary Outcome Measures:

Microvascular obstruction [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up
Left ventricular remodeling [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up

Estimated Enrollment:	60
Study Start Date:	July 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Control	Procedure: Control Deflated blood pressure cuff placed on upper arm for 30min
Active Comparator: RIPer Remote ischemic preconditioning	Procedure: RIPer 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.
Active Comparator: RIPer + IPost Remote ischemic preconditioning and Local ischemic postconditioning	Procedure: RIPer + 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390142

Contacts

Contact: Fabrice Prunier, MD, PhD

+33 (0)2 41 35 51 47

FaPrunier@chu-angers.fr

Locations

France
CHU Angers - Service de Cardiologie	Recruiting
Angers, France, 49933
Contact: Fabrice Prunier, MD, PhD +33 (0)2 41 35 51 47 FaPrunier@chu-angers.fr

Sponsors and Collaborators

University Hospital, Angers

Fédération Française de Cardiologie

Société Française de Cardiologie

Investigators

Principal Investigator:

Fabrice Prunier, MD, PhD

University Hospital, Angers

More Information

No publications provided

Responsible Party:	University Hospital, Angers, Direction des Affaires Médicales et de la Recherche
ClinicalTrials.gov Identifier:	NCT01390142 History of Changes
Other Study ID Numbers:	PHRC 2011-06
Study First Received:	July 6, 2011
Last Updated:	July 8, 2011
Health Authority:	France: Ministry of Health

Additional relevant MeSH terms:

Infarction
Ischemia
Myocardial Infarction
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012