Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction
- Conditions
- ST Elevation Myocardial Infarction
- Interventions
- Procedure: RIC + PostC + Standard PCIProcedure: Standard PCI
- Registration Number
- NCT04844931
- Lead Sponsor
- Helios Health Institute GmbH
- Brief Summary
The RIP-HIGH trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning (RIP) and local ischemic postconditioning (PostC) vs. standard of care on clinical outcome in high-risk ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.
- Detailed Description
Coronary reperfusion by percutaneous coronary intervention is mandatory to salvage ischemic myocardium and to reduce definite infarct size. However, reperfusion itself also causes irreversible myocardial damage - a phenomenon described as reperfusion injury. Reduction of ischemic and reperfusion injury by ischemic conditioning has been identified as a potential target to reduce myocardial damage.
Remote ischemic conditioning and local ischemic postconditioning might be in particular of clinical benefit in higher risk STEMI patients with Killip class ≥2, where mortality rates are high.
The Remote Ischemic Conditioning with Local Ischemic Postconditioning in High-Risk ST-elevation myocardial infarction patients (RIP-HIGH) trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning and local ischemic postconditioning vs. standard of care on clinical outcome in high-risk ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Acute chest pain lasting <12 h
- ST-elevation at the J-point in two contiguous leads of ≥2 mm in men ≥40 years, ≥2.5 mm in men <40 years and ≥1.5 mm in women (regardless of age) in V2-V3 and/or ≥1 mm in all other leads (52).
- New or presumed new left bundle branch block or right bundle branch block.
- Killip class ≥II on hospital admission or requirement of diuretics because of clinical congestion.
- Written informed consent.
- Killip class I on hospital admission.
- Prior fibrinolysis.
- Conditions precluding use of RIC (i.e. paresis of the upper limb, presence of an arteriovenous shunt).
- Pregnancy.
- Age <18 years.
- Severe co-morbidity with a life expectancy <6 months.
- Participation in another trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIC + PostC in addition to standard treatment RIC + PostC + Standard PCI RIC by arm ischemia initiated on hospital admission plus local PostC by re-inflating the angioplasty balloon after re-opening the infarct-related artery in addition to standard treatment. Standard treatment Standard PCI -
- Primary Outcome Measures
Name Time Method Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization. 12 months
- Secondary Outcome Measures
Name Time Method All-cause mortality at 12 months 12 months Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months 12 months Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI day 0 Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion day 0 all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact. 5 years CMR-derived infarct size. day 2-5 CMR-derived myocardial salvage index day 2-5 Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization day 3 Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization day 0, day 3 Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization day 2-5 Cardiovascular mortality at 12 months. 12 months Hospitalization for heart failure at 12 months 12 months
Trial Locations
- Locations (11)
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria
Klinikum Links der Weser
🇩🇪Bremen, Germany
Herzzentrum Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
University Hospital Essen
🇩🇪Essen, Germany
University Clinic Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
🇩🇪Leipzig, Germany
Klinikum Ludwigshafen
🇩🇪Ludwigshafen, Germany
University Heart Center Lübeck - University of Schleswig-Holstein
🇩🇪Lübeck, Germany
Universitätsmedizin Rostock
🇩🇪Rostock, Germany
University Hospital Tübingen
🇩🇪Tübingen, Germany