Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction
NCT03155022 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750
Last updated 2026-05-08
Summary
Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of these two interventions may improve clinical outcome after STEMI remains unknown. The objective of the present study is to determine whether combination of ICIC and RIC can improve STEMI patients clinical outcome at 6 months.
Conditions
- Myocardial Infarction, Acute
Interventions
- DEVICE
-
Remote ischemic conditioning and intracoronary ischemic conditioning
RIC: Four cycles of \[5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation\] started as soon as possible prior to PCI reperfusion. At least one full cycle (inflation + deflation) has to be completed before PCI reperfusion. ICIC: Four cycles of \[1 min balloon inflation followed by 1 min balloon deflation\] started as soon as possible after reopening of the culprit coronary artery (maximum within 3 minutes after reflow). The balloon will be placed carefully above the culprit lesion so as to minimize potential micro-embolization.
- DEVICE
-
Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning
Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.
Sponsors & Collaborators
-
Hospices Civils de Lyon
lead OTHER
Principal Investigators
-
Gilles Rioufol, Pr · Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-12
- Primary Completion
- 2023-10-03
- Completion
- 2023-10-03
Countries
- Belgium
- France
Study Locations
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