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

This study has been completed.
Sponsor:
Collaborators:
Fédération Française de Cardiologie
Société Française de Cardiologie
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01390142
First received: July 6, 2011
Last updated: October 17, 2013
Last verified: October 2013
  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:


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


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01390142     History of Changes
Other Study ID Numbers: PHRC 2011-06
Study First Received: July 6, 2011
Last Updated: October 17, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014