Clinical trial NCT04844931: Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction
Official title: Randomized Comparison of Combined Remote Ischemic Conditioning and Local Postconditioning Compared to Standard Treatment in High-risk ST-elevation Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: remote ischemic conditioning
local ischemic postconditioning
percutaneous coronary intervention
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
First posted: 2021-04-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomized to one of the two groups in a 1:1 ratio stratified by center
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality at 12 months
timeFrame: 12 months
measure: Hospitalization for heart failure at 12 months
timeFrame: 12 months
measure: Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months
timeFrame: 12 months
measure: Cardiovascular mortality at 12 months.
timeFrame: 12 months
measure: Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization
timeFrame: day 3
measure: Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization
timeFrame: day 0, day 3
measure: Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI
timeFrame: day 0
measure: Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion
timeFrame: day 0
measure: CMR-derived infarct size.
timeFrame: day 2-5
measure: CMR-derived myocardial salvage index
timeFrame: day 2-5
measure: Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization
timeFrame: day 2-5
measure: all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact.
timeFrame: 5 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: University Hospital Essen
city: Hamburg
country: Germany
facility: University Clinic Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Lübeck
country: Germany
facility: University Heart Center Lübeck - University of Schleswig-Holstein
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Holger Thiele, Prof. Dr.
role: STUDY_CHAIR
References: