---
title: Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction
nct_id: NCT04844931
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Helios Health Institute GmbH
study_type: INTERVENTIONAL
primary_condition: ST Elevation Myocardial Infarction
countries: Austria, Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04844931.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04844931"
ct_last_update_post_date: 2025-03-13
last_seen_at: "2026-05-12T07:10:41.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04844931](https://clinicaltrials.gov/study/NCT04844931)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 250
- **Lead Sponsor:** Helios Health Institute GmbH
- **Collaborators:** Heart Center Leipzig - University Hospital
- **Conditions:** ST Elevation Myocardial Infarction
- **Start Date:** 2021-07-05
- **Completion Date:** 2030-07-01
- **CT.gov Last Update:** 2025-03-13

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **RIC + PostC in addition to standard treatment** (EXPERIMENTAL) — 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.
- **Standard treatment** (ACTIVE_COMPARATOR)

## Interventions

- **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

- **Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.** _(time frame: 12 months)_

## Secondary Outcomes

- **All-cause mortality at 12 months** _(time frame: 12 months)_
- **Hospitalization for heart failure at 12 months** _(time frame: 12 months)_
- **Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months** _(time frame: 12 months)_
- **Cardiovascular mortality at 12 months.** _(time frame: 12 months)_
- **Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization** _(time frame: day 3)_
- **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)_
- **Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI** _(time frame: day 0)_
- **Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion** _(time frame: day 0)_
- **CMR-derived infarct size.** _(time frame: day 2-5)_
- **CMR-derived myocardial salvage index** _(time frame: day 2-5)_
- **Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization** _(time frame: day 2-5)_
- **all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact.** _(time frame: 5 years)_

## Locations (11)

- Medizinische Universität Innsbruck, Innsbruck, Austria
- 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
- Klinikum Ludwigshafen, Ludwigshafen, Germany
- University Heart Center Lübeck - University of Schleswig-Holstein, Lübeck, Germany
- Universitätsmedizin Rostock, Rostock, Germany
- University Hospital Tübingen, Tübingen, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `locations.universitätsmedizin rostock|rostock||germany` — added _(2026-05-12)_
- `locations.university hospital tübingen|tübingen||germany` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.medizinische universität innsbruck|innsbruck||austria` — added _(2026-05-12)_
- `locations.klinikum links der weser|bremen||germany` — added _(2026-05-12)_
- `locations.herzzentrum dresden|dresden||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum düsseldorf|düsseldorf||germany` — added _(2026-05-12)_
- `locations.university hospital essen|essen||germany` — added _(2026-05-12)_
- `locations.university clinic hamburg-eppendorf|hamburg||germany` — added _(2026-05-12)_
- `locations.heart center leipzig at university of leipzig, department of internal medicine/cardiology|leipzig||germany` — added _(2026-05-12)_
- `locations.klinikum ludwigshafen|ludwigshafen||germany` — added _(2026-05-12)_
- `locations.university heart center lübeck - university of schleswig-holstein|lübeck||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04844931.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04844931*  
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