ST Elevation Myocardial Infarction
Conditions
Keywords
remote ischemic conditioning, local ischemic postconditioning, percutaneous coronary intervention
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.
Interventions
PROCEDURERIC + 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
PROCEDUREStandard PCI
Standard PCI
Sponsors
Helios Health Institute GmbH
Heart Center Leipzig - University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients will be randomized to one of the two groups in a 1:1 ratio stratified by center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization for heart failure at 12 months | 12 months |
| Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months | 12 months |
| Cardiovascular mortality at 12 months. | 12 months |
| Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization | day 3 |
| Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization | day 0, day 3 |
| All-cause mortality at 12 months | 12 months |
| Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion | day 0 |
| CMR-derived infarct size. | day 2-5 |
| CMR-derived myocardial salvage index | day 2-5 |
| Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization | day 2-5 |
| all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact. | 5 years |
| Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI | day 0 |
Countries
Austria, Germany
Outcome results
None listed