Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction
NCT ID: NCT01390142
Last Updated: 2013-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2011-07-31
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Control
Deflated blood pressure cuff placed on upper arm for 30min
RIPer
Remote ischemic preconditioning
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.
RIPer + IPost
Remote ischemic preconditioning and Local ischemic postconditioning
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.
Interventions
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Control
Deflated blood pressure cuff placed on upper arm for 30min
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.
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.
Eligibility Criteria
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Inclusion Criteria
* ST-Segment elevation myocardial infarction \<6h
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fédération Française de Cardiologie
OTHER
Société Française de Cardiologie
OTHER
University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Fabrice Prunier, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Locations
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CHU Angers - Service de Cardiologie
Angers, , France
Countries
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Other Identifiers
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PHRC 2011-06
Identifier Type: -
Identifier Source: org_study_id