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- Ensaio Clínico NCT04878133
Pci guiada por OCT vs COMPLETA em pacientes com elevação do segmento sT, infarto do miocárdio e doença multiarterial (OCT-CONTACT)
STEMI patients with multivessel disease will be randomized to complete PCI versus PCI driven by high risk criteria of plaques evaluated with OCT
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In patients with ST segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significally reduces the risk of cardiovascular death. How to manage in this setting non-culprit lesion in patients with multivessel disease still remain a matter of debate. Recently, the COMPLETE trial showed that complete PCI of every coronary stenosis > 70% (or 50-69% lesions with FFR < 0.8) reduces risk of myocardial infarction (MI) and unstable angina (UA) at 3 years compared with culprit-lesion PCI [1]. Whether this findings are related to revascularization of every obstructive lesions rather than lesions with vulnerable-plaque characteristics, still remain unclear.
In high risk patients such as STEMI patients, physiopathology of coronary plaque deeply differs from stable angina, mainly due to peculiar features of plaque. STEMI lesions, when evaluated at autopsy or at intracoronary imaging, showed a pro-thrombotic pattern, with high prevalence of thin cap fibro-atheroma, plaque rupture or thrombus, and a larger amount of lipids and macrophage [2-6]. In this setting, angiography, even when combined with fractional flow reserve evaluation (which can describe more accurately the functional impact of the plaque), has intrinsic limitations because of lack of information about plaque characteristics [7,8].
Optical coherence tomography (OCT) is the latest development in intravascular coronary imaging. Similarly to intravascular ultrasound (IVUS), OCT provides cross-sectional images of the vessel. However, instead of sound, OCT employs light for tissue analysis that enables visualization of the coronary lesions with almost microscopic precision [9,10].
This tool can find high risk vulnerable plaque without angiographic or functional signs of severity, helping from misdiagnosing and under-treating these lesions, that could benefit from PCI even more than obstructive lesions without vulnerable plaque characteristics.
In an OCT substudy of the COMPLETE trial, researchers determined that half of patients had obstructive nonculprit lesions with vulnerable plaque, which could explain why complete revascularization conferred better outcomes than culprit lesion-only revascularization in the main trial. This substudy pointed out also a 20% of non-obstructive non-culprit lesions with vulnerable plaque caracteristics and up to 30% of obstructive non-culprit lesions without high risk morphology [11]. It suggest that a morphological approach to PCI in high risk patients can provide a more specific treatment compared with standard angiographic/functional approach. A correct identification of coronary plaque instability in a setting of STEMI patients could deeply impact in these patients risk of cardiovascular events, angina and re- hospitalization.
Being coronary artery disease a pandemic disease with an important impact on nations health care, a reduction in events in these patients do not impact only on patients quality of life, but on health care system resources.
Consequently, we propose a randomized controlled trial to evaluate the effective benefit of OCT guided vs complete PCI in STEMI patients with multivessels coronary artery disease.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Orbassano, Itália, 10043
- Ospedale San Luigi Gonzaga, Orbassano
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Italy
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Rivoli, Italy, Itália, 10098
- Ospedale di Rivoli
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Torino, Italy, Itália, 10126
- AOU Città della Salute e della Scienza di Torino
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Torino, Italy, Itália, 10144
- Ospedale San Giovanni Bosco
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Piedmont
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Turin, Piedmont, Itália, 10100
- Città della Salute e della Scienza di Torino
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Turin
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Turin, Turin, Itália, 10128
- Citta della Salute
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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:
- Patients with STEMI and residual non culprit CAD
- Informed consent
Exclusion Criteria:
- Refusal or inability to provide informed consent.
- < 18 years of age
- Cardiogenic shock
- Previous Coronary Artery Bypass Grafting (CABG
- Indication for revascularization by CABG.
- eGFR < 30 ml/min/m2
- ULM stenosis
- Estimated life expectancy < 3 year
- Non culprit CTO lesion
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Braço de controle
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Experimental: Exsperimental Arm
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The principle by which OCT works is similar to ultrasound, although light waves close to infrared are used instead of ultrasounds. In practice, the light waves, emitted into the vessel through a special catheter positioned in the coronary artery, meet the surrounding structures and are partly absorbed and partly reflected by them. The reflected waves are picked up by a sensor positioned on the catheter and analyzed through software that produces images visible live on a special console. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Major adverse cardiovascular events (MACE)
Prazo: 24 mounth after the recruitment in the study
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Composite endopoint of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization. |
24 mounth after the recruitment in the study
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Secondary efficacy end-points
Prazo: 24 mounth after the recruitment in the study
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Rate of all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, unplanned revascularization taking separately. |
24 mounth after the recruitment in the study
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety end-points
Prazo: 24 mounth after the recruitment in the study
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Rate of Acute kidney injury (AKI) following OCT vs complete guided PCI, defined according to the Acute Kidney Injury Network criteria |
24 mounth after the recruitment in the study
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Safety end-points
Prazo: 24 mounth after the recruitment in the study
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Rate of procedural complications following each PCI: periprocedural MI defined according to the Fourth Universal Definition of Myocardial Infarction [15], arterial access site complications, AKI |
24 mounth after the recruitment in the study
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- OCT - 001621
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