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

ST Elevation Myocardial Infarction Clinical Trial

— RIP-HIGH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844931
• Other study ID #: 2021-0089
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: December 1, 2030

Study information

• Verified date: September 2023
• Source: Helios Health Institute GmbH
• Contact: Holger Thiele, Prof. Dr.
• Phone: +49 341 865 1428
• Email: holger.thiele[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2030
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• RIC + 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
• Standard PCI
Standard PCI

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
Germany	Klinikum Links der Weser	Bremen
Germany	Herzzentrum Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	University Hospital Essen	Essen
Germany	University Clinic Hamburg-Eppendorf	Hamburg
Germany	Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology	Leipzig
Germany	University Heart Center Lübeck - University of Schleswig-Holstein	Lübeck
Germany	Klinikum Ludwigshafen	Ludwigshafen
Germany	Universitätsmedizin Rostock	Rostock
Germany	University Hospital Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
Helios Health Institute GmbH	Heart Center Leipzig - University Hospital

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.		12 months
Secondary	All-cause mortality at 12 months		12 months
Secondary	Hospitalization for heart failure at 12 months		12 months
Secondary	Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months		12 months
Secondary	Cardiovascular mortality at 12 months.		12 months
Secondary	Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization		day 3
Secondary	Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization		day 0, day 3
Secondary	Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI		day 0
Secondary	Proportion of patients showing complete (=70%) resolution of ST-segment elevation 60 minutes after reperfusion		day 0
Secondary	CMR-derived infarct size.		day 2-5
Secondary	CMR-derived myocardial salvage index		day 2-5
Secondary	Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization		day 2-5
Secondary	all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact.		5 years