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Active Not RecruitingNCT04844931

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
250 (actual)
Sponsor
Helios Health Institute GmbH · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURERIC + PostC + Standard PCIRIC by arm ischemia initiated on hospital admission plus local PostC by re-inflating the angioplasty balloon after re-opening the infarct-related artery
PROCEDUREStandard PCIStandard PCI

Timeline

Start date
2021-07-05
Primary completion
2025-12-31
Completion
2030-07-01
First posted
2021-04-14
Last updated
2025-03-13

Locations

11 sites across 2 countries: Austria, Germany

Source: ClinicalTrials.gov record NCT04844931. Inclusion in this directory is not an endorsement.