Postconditioning in ST-elevation Myocardial Infarction (POSTEMI)
Postconditioning in ST-elevation Myocardial Infarction Treated With Primary PCI
Study objectives: To assess the effects of postconditioning on infarct size in patients with ST-elevation infarction referred to PCI.
Study design: Prospective, randomized, open-label study with blinded endpoint evaluation. Included patients will be randomly allocated to postconditioning or control. Patients with symptoms of acute myocardial infarction of less than 6 hours duration fulfilling ECG criteria for primary PCI are eligible. PCI follow established routines. In postconditioning patients, additional, short (1 min), intermittent balloon occlusions will be applied after initial opening of infarct related artery. After this intervention, PCI proceeds routinely with stent implantation. In the control group, stent implantation after initial opening proceeds as usual. Primary endpoint is final infarct size, determined by MRI after 4 months. 260 patients will be included. Follow-up is 1 year. Inclusion period: 18 - 24 months.
Clinical implications: Reperfusion therapy, administered as early as possible after start of symptoms, has improved the prognosis in acute ST-elevation myocardial infarction. Still, however, many patients suffer large infarctions, subsequently with an increased risk of heart failure, arrhythmias, and death. In pilot studies, mechanical postconditioning has been shown to reduce infarct size and thus potentially improve prognosis. However, the effect of postconditioning must be confirmed in larger clinical trials before implemented in routine treatment.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Oslo, Norvegia, N-0407
- Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- acute symptoms consistent with an acute myocardial infarction of less than 6 hours duration
- an occluded infarct related artery must be demonstrated (TIMI-flow 0-1)
Exclusion Criteria:
- Prior myocardial infarction
- Demonstration of collaterals to the infarcted area
- TIMI-flow >1 before intervention or TIMI-flow <2 after initial balloon inflation
- Demonstration of a distal occlusion
- Patients given thrombolytic treatment
- Patients in cardiogenic shock
- Any contraindication to MRI (magnetic resonance imaging)
- Unwillingness to participate
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Postconditioning
Active arm:Postconditioning protocol before routine PCI/stenting of an occluded coronary artery
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After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
In the postconditioning group 4 additional balloon inflations separated by 1 minute reperfusion are given, starting after 1 minute of reperfusion.
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Altro: Control
Control arm: Routine PCI/stenting of an occluded coronary artery without postconditioning
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After opening of IRA and establishment of TIMI-flow grade 2 or 3, the control group continues the procedure with stenting.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Infarct size, assessed by MRI
Lasso di tempo: 4 months
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4 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Myocardial blushing grade
Lasso di tempo: assessed at the end of PCI procedure
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assessed at the end of PCI procedure
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ST-resolution in ECG
Lasso di tempo: Assessed after 1 hour
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Assessed after 1 hour
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Troponin-T and CK-MB
Lasso di tempo: peak release values
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peak release values
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Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.
Lasso di tempo: assessed at baseline, 4 months and1 year
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Assesment of LV function.
Comparison with CMR in the whole study population and between treatment groups.
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assessed at baseline, 4 months and1 year
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Incidence of treated arrhythmias and heart failure during initial hospitalization Incidence of death, non-fatal myocardial infarction, unstable angina, heart failure, and cerebrovascular disease
Lasso di tempo: 1-year follow up.
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1-year follow up.
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Myocardial salvage
Lasso di tempo: Baseline to 4 months
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Myocardial salvage defined as (area at risk-final infarct size)/area at risk.
Area at risk measured by CMR at baseline and final infarct size by CMR at 4 months.
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Baseline to 4 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Jan Eritsland, MD, PhD, Oslo Univ.Hosp. Ulleval
Pubblicazioni e link utili
Pubblicazioni generali
- Tollefsen IM, Shetelig C, Seljeflot I, Eritsland J, Hoffmann P, Andersen GO. High levels of interleukin-6 are associated with final infarct size and adverse clinical events in patients with STEMI. Open Heart. 2021 Dec;8(2):e001869. doi: 10.1136/openhrt-2021-001869.
- Limalanathan S, Andersen GO, Klow NE, Abdelnoor M, Hoffmann P, Eritsland J. Effect of ischemic postconditioning on infarct size in patients with ST-elevation myocardial infarction treated by primary PCI results of the POSTEMI (POstconditioning in ST-Elevation Myocardial Infarction) randomized trial. J Am Heart Assoc. 2014 Apr 23;3(2):e000679. doi: 10.1161/JAHA.113.000679.
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Po 1506
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