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In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic postconditioning reduces reperfusion injury and this will translate into improved clinical outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing primary PCI
Myocardial reperfusion with the use primary percutaneous coronary intervention (PCI) is effective, but restoration of blood flow may itself jeopardize the myocardium, a phenomenon known as reperfusion injury.
In ischemic postconditioning (iPOST), repetitive interruptions of blood flow to the injured region applied after initial reperfusion, has been shown favorable with different modalities such as biomarkers, echocardiography and cardiac magnetic resonance.
However, the largest trial to date (DANAMI3-iPOST) failed to show clinical favor of iPOST when compared to conventional PCI. Importantly, however, in DANAMI3-iPOST thrombectomy was allowed and this might have impaired postconditioning, since thrombectomy itself creates reperfusion and thus reperfusion damage. Analysis of the fraction of DANAMI3-iPOST patients not undergoing thrombectomy showed a remarkable 45% reduction in death and heart failure in favor of postconditioning.
iPOST2 will investigate in a randomized, prospective and adequately powered trial the effect of iPOST without thrombectomy compared to conventional PCI on the development of heart failure and death in STEMI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic postconditioning | Active Comparator | In addition to state of the art primary PCI in patients with TIMI0-1 ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed, however thrombectomy will not be allowed |
|
| Conventional | Placebo Comparator | State of the art primary PCI in patients with TIMI0-1 will be performed, however thrombectomy will not be allowed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ischemic postconditioning | Procedure | After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality or hospitalization for heart failure | Composite endpoint of all cause mortality or hospitalization for heart failure which ever occur first | From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | All cause mortality | From date of randomization until the date of first documented death from any cause assessed up to 280 events have been adjudicated or up to 36 months |
| Percentage of patients hospitalized for heart failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Engstrøm, DMSci | Contact | +4535458444 | thomas.engstroem@regionh.dk | |
| Jacob Lønborg, DMSci | Contact | +4535458176 | jacob.thomsen.loenborg01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Engstrøm, DMSci | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Center, Rigshospitalet, University of Copenhagen | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28249094 | Result | Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Clemmensen P, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aaroe J, Jensen SE, Raungaard B, Botker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lonborg J, Kober L; Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction-Ischemic Postconditioning (DANAMI-3-iPOST) Investigators. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D057775 | Ischemic Postconditioning |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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Prospective, randomized, placebo controlled
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All study personell involved in outcome assessment will be blinded to the treatment employed
| Conventional | Procedure | State of the art primary PCI, however thrombectomy is not allowed |
|
Any hospitalization for heart failure occurring after the index STEMI
| From date of randomization until the date of first documented hospitalization for heart failure assessed up to 280 events have been adjudicated or up to 36 months |
| Percentage of patients with myocardial infarction | Any myocardial infarction occurring after the index STEMI | From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months |
| Cardiovascular death | Cardiovascular death | From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months |
| Percentage of patients with stroke | An acute episode of focal or global neurological dysfunction caused by brain injury | From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months |
| Percentage of patients with a combination of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia | Composite endpoint of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia | From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months |
| Percentage of patients with a combination of hospitalization for heart failure and cardiovascular death | A composite of hospitalization for heart failure and cardiovascular death | From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months |
| Danish eq5d5l standard Quality of life | Self assesed quality of life after the Danish eq5d5l standard scale (1 worst score -100 best score) | 1 year |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |