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

N/AActive Not RecruitingNCT04844931

Helios Health Institute GmbH250 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

ST Elevation Myocardial Infarction

Interventions

RIC + PostC + Standard PCIPROCEDURE

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 PCIPROCEDURE

Standard PCI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Medizinische Universität Innsbruck

Innsbruck, Austria

Klinikum Links der Weser

Bremen, Germany

Herzzentrum Dresden

Dresden, Germany

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

All-cause mortality at 12 months

Time frame: 12 months

Hospitalization for heart failure at 12 months

Time frame: 12 months

Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months

Time frame: 12 months

Cardiovascular mortality at 12 months.

Time frame: 12 months

Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization

Time frame: day 3

Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization

Time frame: day 0, day 3

Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI

Time frame: day 0

Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion

Time frame: day 0

CMR-derived infarct size.

Time frame: day 2-5

CMR-derived myocardial salvage index

Data from ClinicalTrials.gov

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