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

NCT ID: NCT04844931

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2030-07-01

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.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RIC + PostC in addition to standard treatment

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.

Group Type: EXPERIMENTAL

RIC + PostC + Standard PCI

Intervention Type: PROCEDURE

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 treatment

Group Type: ACTIVE_COMPARATOR

Standard PCI

Intervention Type: PROCEDURE

Standard PCI

Interventions

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

Intervention Type: PROCEDURE

Standard PCI

Standard PCI

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: collaborator

Helios Health Institute GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holger Thiele, Prof. Dr.

Role: STUDY_CHAIR

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Locations

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

Countries

Austria; Germany

Other Identifiers

2021-0089

Identifier Type: -

Identifier Source: org_study_id