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

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ClinicalTrials.gov Identifier: NCT04844931
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : February 2, 2022
Sponsor:
Collaborator:
Heart Center Leipzig - University Hospital
Information provided by (Responsible Party):
Leipzig Heart Institute GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Procedure: RIC + PostC + Standard PCI Procedure: Standard PCI Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients will be randomized to one of the two groups in a 1:1 ratio stratified by center
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Combined Remote Ischemic Conditioning and Local Postconditioning Compared to Standard Treatment in High-risk ST-elevation Myocardial Infarction Patients
Actual Study Start Date : July 5, 2021
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : December 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: RIC + PostC 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 in addition to standard treatment.
 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
Active Comparator: Standard treatment Procedure: Standard PCI
Standard PCI


Outcome Measures
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Primary Outcome Measures :
  1. Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization. [ Time Frame: 12 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844931


Contacts
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Contact: Holger Thiele, Prof. Dr. +49 341 865 1428 holger.thiele@medizin.uni-leipzig.de
Contact: Hans-Josef Feistritzer, Dr. med. +49 341 865 1428 hans-josef.feistritzer@medizin.uni-leipzig.de

Locations
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Germany
Klinikum Links der Weser Recruiting
Bremen, Germany
Contact: Harm Wienbergen, Prof.         
Contact: Andreas Fach, Dr.         
University Hospital Essen Recruiting
Essen, Germany
Contact: Tienush Rassaf, Prof.         
Contact: Amir Abbas Mahabadi, Prof.         
University Clinic Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Peter Clemmensen, Prof.         
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology Recruiting
Leipzig, Germany, 04289
Contact: Holger Thiele, Prof. Dr.    +49 341 865 1428    holger.thiele@medizin.uni-leipzig.de   
Contact: Hans-Josef Feistritzer, Dr. med.    +49 341 865 1428    hans-josef.feistritzer@medizin.uni-leipzig.de   
Universitätsmedizin Rostock Recruiting
Rostock, Germany
Contact: Alper Öner, Prof.         
Contact: Hüseyin Ince, Prof.         
Sponsors and Collaborators
Leipzig Heart Institute GmbH
Heart Center Leipzig - University Hospital
Investigators
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Study Chair: Holger Thiele, Prof. Dr. Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
More Information
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Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT04844931    
Other Study ID Numbers: 2021-0089
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leipzig Heart Institute GmbH:
remote ischemic conditioning
local ischemic postconditioning
percutaneous coronary intervention
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Infarction
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases