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Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

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ClinicalTrials.gov Identifier: NCT01390142
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : October 18, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Control Procedure: RIPer Procedure: RIPer + IPost Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)
Study Start Date : July 2011
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Infarct size [ Time Frame: 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 Outcome Measures :
  1. Microvascular obstruction [ Time Frame: 5 days ]
    Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up

  2. Left ventricular remodeling [ Time Frame: 3 months ]
    Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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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): NCT01390142


Locations
France
CHU Angers - Service de Cardiologie
Angers, France, 49933
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

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01390142     History of Changes
Other Study ID Numbers: PHRC 2011-06
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: October 18, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases