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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Oslo, Noruega, N-0407
- Dept. of Cardiology, Oslo Univ. Hosp. Ulleval
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Infarct size, assessed by MRI
Prazo: 4 months
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4 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Myocardial blushing grade
Prazo: 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
Prazo: Assessed after 1 hour
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Assessed after 1 hour
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Troponin-T and CK-MB
Prazo: peak release values
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peak release values
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Echocardiographic evaluation of left ventricular function including speckle-tracking measurement.
Prazo: 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
Prazo: 1-year follow up.
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1-year follow up.
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Myocardial salvage
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Jan Eritsland, MD, PhD, Oslo Univ.Hosp. Ulleval
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Po 1506
Plano para dados de participantes individuais (IPD)
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