Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction (RIP-HIGH)

Helios Health Institute GmbH

Status: Active, not recruiting

Conditions: ST Elevation Myocardial Infarction

Treatments: Procedure: RIC + PostC + Standard PCI; Procedure: Standard PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT04844931

2021-0089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

RIC + PostC in addition to standard treatment

Experimental group

Description:

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.

Treatment:

Procedure: RIC + PostC + Standard PCI

Standard treatment

Active Comparator group

Treatment:

Procedure: Standard PCI