ST Elevation Myocardial InfarctionRIP-HIGHNCT04844931
Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction
A study testing RIC + PostC + Standard PCI and Standard PCI in people with ST Elevation Myocardial Infarction, run by Helios Health Institute GmbH at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- RIC + PostC + Standard PCI and Standard PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 5 Jul 2021to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany10 sites
Klinikum Links der Weser
Bremen
Herzzentrum Dresden
Dresden, 01307
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
University Hospital Essen
Essen
University Clinic Hamburg-Eppendorf
Hamburg, 20246
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, 04289
University Heart Center Lübeck - University of Schleswig-Holstein
Lübeck, 23538
Klinikum Ludwigshafen
Ludwigshafen, 67063
Universitätsmedizin Rostock
Rostock
University Hospital Tübingen
Tübingen, 72076
About this study
Official title: Randomized Comparison of Combined Remote Ischemic Conditioning and Local Postconditioning Compared to Standard Treatment in High-risk ST-elevation Myocardial Infarction Patients
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.
Read the 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
- ST Elevation Myocardial Infarction
- Being tested
- RIC + PostC + Standard PCI, Standard PCI
- Keywords
- remote ischemic conditioning, local ischemic postconditioning, percutaneous coronary intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIC + PostC + Standard PCIProcedure or surgery
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 PCIProcedure or surgery
Standard PCI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: RIC + PostC + Standard PCI |
| Standard treatment | Active comparator | Not described Receives: Procedure: Standard PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.
Measured: 12 months
Secondary outcomes (12)
All-cause mortality at 12 months
Measured: 12 months
Hospitalization for heart failure at 12 months
Measured: 12 months
Composite of all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest at 12 months
Measured: 12 months
Cardiovascular mortality at 12 months.
Measured: 12 months
Enzymatic infarct size defined as high-sensitivity cardiac troponin T (hs-TnT) levels 72 h after randomization
Measured: day 3
Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization
Measured: day 0, day 3
Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI
Measured: day 0
Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion
Measured: day 0
CMR-derived infarct size.
Measured: day 2-5
CMR-derived myocardial salvage index
Measured: day 2-5
Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization
Measured: day 2-5
all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start5 Jul 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomized to one of the two groups in a 1:1 ratio stratified by center
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Responsible party
- Sponsor
- Investigators
- Holger Thiele, Prof. Dr., Study chair, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844931
- Sponsor's protocol ID
- 2021-0089
- Acronym
- RIP-HIGH
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Combined Remote Ischemic Conditioning and Local Postconditioning Compared to Standard Treatment in High-risk ST-elevation Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT04844931
- Acronym / sponsor ID
- RIP-HIGH / 2021-0089
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- remote ischemic conditioning, local ischemic postconditioning, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients will be randomized to one of the two groups in a 1:1 ratio stratified by center
| Arm | Type | Receives |
|---|---|---|
| RIC + PostC in addition to standard treatment | Experimental | Procedure: RIC + 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 in addition to standard treatment. |
| Standard treatment | Active comparator | Procedure: Standard PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIC + 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 | Procedure or surgery | RIC + PostC in addition to standard treatment |
| Standard PCIStandard PCI | Procedure or surgery | Standard treatment |
Primary outcome
Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization.
Time frame: 12 months
12 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Thiele, Prof. Dr. study chair
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIC + PostC + Standard PCI and Standard PCI in people with ST Elevation Myocardial Infarction, run by Helios Health Institute GmbH at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.