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

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

Randomized Comparison of Combined Remote Ischemic Conditioning and Local Postconditioning Compared to Standard Treatment in High-risk ST-elevation Myocardial Infarction Patients

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.

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.

RIC by arm ischemia initiated on hospital admission plus local PostC by re-inflating the angioplasty balloon after re-opening the infarct-related artery

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

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

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

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

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

all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact.

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.