NCT04844931

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
50mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jul 2021Jul 2030

First Submitted

Initial submission to the registry

March 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 5, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Expected
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

March 31, 2021

Last Update Submit

March 10, 2025

Conditions

ST Elevation Myocardial Infarction

Keywords

remote ischemic conditioninglocal ischemic postconditioningpercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (12)

  • All-cause mortality at 12 months

    12 months

  • Hospitalization for heart failure at 12 months

    12 months

  • Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months

    12 months

  • Cardiovascular mortality at 12 months.

    12 months

  • Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization

    day 3

  • +7 more secondary outcomes

Study Arms (2)

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.

Procedure: RIC + PostC + Standard PCI

Standard treatment

ACTIVE COMPARATOR
Procedure: Standard PCI

Interventions

RIC + PostC + Standard PCIPROCEDURE

RIC by arm ischemia initiated on hospital admission plus local PostC by re-inflating the angioplasty balloon after re-opening the infarct-related artery

RIC + PostC in addition to standard treatment
Standard PCIPROCEDURE

Standard PCI

Standard treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Klinikum Links der Weser

Bremen, Germany

Location

Herzzentrum Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

University Hospital Essen

Essen, Germany

Location

University Clinic Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Leipzig, 04289, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

University Heart Center Lübeck - University of Schleswig-Holstein

Lübeck, 23538, Germany

Location

Universitätsmedizin Rostock

Rostock, Germany

Location

University Hospital Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Holger Thiele, Prof. Dr.

    Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients will be randomized to one of the two groups in a 1:1 ratio stratified by center
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 14, 2021

Study Start

July 5, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 1, 2030

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

DE(10)AU(1)