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| Name | Class |
|---|---|
| Heart Center Leipzig - University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality or hospitalization for heart failure (HF) within 12 months after randomization. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, Prof. Dr. | Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria | |||
| Klinikum Links der Weser |
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patients will be randomized to one of the two groups in a 1:1 ratio stratified by center
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| Standard PCI | Procedure | Standard PCI |
|
| 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 |
| Change in N-terminal pro B-type natriuretic peptide (NT-proBNP) levels during admission and 72 h after randomization | day 0, day 3 |
| Thrombolysis in myocardial infarction (TIMI)-flow grade of the culprit vessel post PCI | day 0 |
| Proportion of patients showing complete (≥70%) resolution of ST-segment elevation 60 minutes after reperfusion | day 0 |
| CMR-derived infarct size. | day 2-5 |
| CMR-derived myocardial salvage index | day 2-5 |
| Extent of CMR-derived late microvascular obstruction on day 2-5 after randomization | day 2-5 |
| all-cause mortality, HF hospitalization and survived out-of-hospital cardiac arrest assessed at 5 years via telephone contact. | 5 years |
| Bremen |
| Germany |
| Herzzentrum Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| University Hospital Essen | Essen | Germany |
| University Clinic Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Leipzig | 04289 | Germany |
| Klinikum Ludwigshafen | Ludwigshafen | 67063 | Germany |
| University Heart Center Lübeck - University of Schleswig-Holstein | Lübeck | 23538 | Germany |
| Universitätsmedizin Rostock | Rostock | Germany |
| University Hospital Tübingen | Tübingen | 72076 | Germany |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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