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NCT Number: NCT04844931

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universität Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RIC + PostC + Standard PCI

Procedure

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

Procedure

Standard PCI

Primary outcomes

  1. Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Collaborators

  • Heart Center Leipzig - University Hospital

Registry information

Official study title

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

Acronym: RIP-HIGH

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Apr 14, 2021
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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