Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Control
RIPer
RIPer + IPost
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
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
Sites / Locations
- CHU Angers - Service de Cardiologie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Control
RIPer
RIPer + IPost
Arm Description
Remote ischemic preconditioning
Remote ischemic preconditioning and Local ischemic postconditioning
Outcomes
Primary Outcome Measures
Infarct size
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
Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up
Left ventricular remodeling
Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up
Full Information
NCT ID
NCT01390142
First Posted
July 6, 2011
Last Updated
October 17, 2013
Sponsor
University Hospital, Angers
Collaborators
Fédération Française de Cardiologie, Société Française de Cardiologie
1. Study Identification
Unique Protocol Identification Number
NCT01390142
Brief Title
Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction
Acronym
RIRE-1
Official Title
Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
Collaborators
Fédération Française de Cardiologie, Société Française de Cardiologie
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Title
RIPer
Arm Type
Active Comparator
Arm Description
Remote ischemic preconditioning
Arm Title
RIPer + IPost
Arm Type
Active Comparator
Arm Description
Remote ischemic preconditioning and Local ischemic postconditioning
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Deflated blood pressure cuff placed on upper arm for 30min
Intervention Type
Procedure
Intervention Name(s)
RIPer
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
RIPer + IPost
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infarct size
Description
Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Microvascular obstruction
Description
Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up
Time Frame
5 days
Title
Left ventricular remodeling
Description
Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Prunier, MD, PhD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers - Service de Cardiologie
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
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Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction
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