Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction
NCT ID: NCT02164695
Last Updated: 2021-11-24
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
NA
118 participants
INTERVENTIONAL
2015-01-31
2018-01-31
Brief Summary
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* Control group: PPCI only
* Study group: PPCI + RIPC
Primary endpoint: Infarct size measured by contrast-enhanced cardiac magnetic resonance (CMR) at 6 months after the index procedure
Detailed Description
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Remote ischemic conditioning uses brief ischemia and reperfusion of a distant organ to protect the myocardium. In animal study, remote ischemic postconditioning seems to be more effective than local postconditioning in experimental myocardial infarction.Bøtker et al. has reported remote ischemic preconditioning before hospital admission increase myocardial salvage in patients with acute myocardial infarction.
The objective of this study is to evaluate whether remote ischemic per-conditioning (RIPC) can reduce late infarct size in patients with STEMI treated with PPCI within 12 hours of symptoms onset. To test this hypothesis, we will randomize patients into PPCI + RIPC or PPCI alone. We will evaluate marker of reperfusion injury using contrast cardiac magnetic resonance image.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* Study group: PPCI + RIPC
TREATMENT
SINGLE
Study Groups
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PPCI plus RIPC
The patients randomized to PPCI plus RIPC group will receive RIPC during PPCI.
PPCI plus RIPC
All patients will be prepared with an upper-arm blood pressure cuff before arterial puncture (contralateral in case of radial access). In patients allocated into PPCI plus RIPC group, the protocol will be started immediately after cuff preparation. Upper-arm will be exposed to 4 cycles of ischemia/reperfusion, each obtained by 5 min cuff inflation at 200mmHg, followed by 5 min complete deflation.
PPCI only
The patients randomized to PPCI only group will receive PPCI only but the sham procedure of RIPC.
PPCI only
All patients randomized to PPCI only arm, the blood pressure cuff will be applied to the arm or the calf but will not be inflated.
Interventions
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PPCI plus RIPC
All patients will be prepared with an upper-arm blood pressure cuff before arterial puncture (contralateral in case of radial access). In patients allocated into PPCI plus RIPC group, the protocol will be started immediately after cuff preparation. Upper-arm will be exposed to 4 cycles of ischemia/reperfusion, each obtained by 5 min cuff inflation at 200mmHg, followed by 5 min complete deflation.
PPCI only
All patients randomized to PPCI only arm, the blood pressure cuff will be applied to the arm or the calf but will not be inflated.
Eligibility Criteria
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Inclusion Criteria
* Presenting within 12 hours of symptom onset
* \>20 min of chest pain
* ST-elevation myocardial infarction defined as ST-segment elevation (\>0.1 mV) in at least 2 contiguous precordial leads
Exclusion Criteria
* Presence of chronic total occlusion
* Evidence of retrograde filling by collaterals at coronary angiography (Rentrop 2 or 3 collateral flow)
* Severe multi-vessel coronary artery disease to require further interventions before follow-up CMR
* Cardiac arrest before randomization
* Arrhythmias requiring external electric shock before randomization
* Unwillingness to participate
* External electric shock for cardioversion within first 3 days
* Cardiac surgery within first 3 days
19 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Young Jin Youn, MD, PhD
Professor, Division of Cardiology, Department of Internal Medicine, Yonsei Univeristy Wonju College of Medicine
Principal Investigators
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Young Jin Youn, MD
Role: PRINCIPAL_INVESTIGATOR
Yonsei Univeristy Wonju College of Medicine
Locations
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Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Countries
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Other Identifiers
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CR314003
Identifier Type: -
Identifier Source: org_study_id