Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction

NCT04844931 · tracked via the Priya Life Science Germany tracker

Sponsor

Helios Health Institute GmbH

Phase

Not applicable

Started

2021-07-05

Last updated

2025-03-13

Condition(s) studied

ST Elevation Myocardial Infarction

Investigational drug(s) / intervention(s)

RIC + PostC + Standard PCIStandard PCI

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

Standard PCI: Standard PCI

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization. — 12 months

Trial sites (11)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04844931 on ClinicalTrials.gov ↗ ← All trials in Germany