The CORE - μFR Clinical Trial
μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes
Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.
The Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.
Patients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is >0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Emanuele Barbato, MD, PhD
- Número de telefone: +39 06 3377 6115
- E-mail: emanuele.barbato@uniroma1.it
Estude backup de contato
- Nome: Emanuele Gallinoro, MD, PhD
- Número de telefone: +39 06 3377 5005
- E-mail: egallinoro@gmail.com
Locais de estudo
-
-
RM
-
Roma, RM, Itália, 00189
- Azienda ospedaliero - universitaria Sant'Andrea
-
Contato:
- Emanuele Barbato, MD, PhD
- Número de telefone: +39 06 3377 6115
- E-mail: emanuele.barbato@uniroma1.it
-
Contato:
- Emanuele Gallinoro, MD, PhD
- Número de telefone: +39 06 3377 5005
- E-mail: egallinoro@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients presenting with ACS within 72 hours of successful culprit PCI
Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics:
- at least 50% diameter stenosis by visual assessment
- a vessel diameter of at least 2.5 mm
- amenable to successful PCI
Exclusion Criteria:
- Cardiogenic shock or severe heart failure (NYHA class ≥III)
- Severely impaired renal function: creatinine >2 mg/dl or estimated glomerular filtration rate (eGFR) <30 ml/min/1,73 m²
- Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated
- Pregnancy or intention to become pregnant during the trial
- Life expectancy less than one year
- Ambiguity in the identification of the culprit vessel/lesion
- Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and/or Tako-Tsubo Syndrome
- Any ambiguity in the diagnosis of ACS
- Inability to provide informed consent
- Patients with only one coronary artery lesion with diameter stenosis >90% and/or TIMI flow <3
- Patients in whom the NCV is treated at the time of the index procedure
- An interrogated lesion is at the site of a myocardial bridge
- An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction
- An interrogated lesion is in a bypass graft
- Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification
- Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement
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 |
|---|---|
|
Comparador Ativo: Group A - Angiography-guided PCI (standard strategy)
Patients will undergo a staged PCI of all non-culprit vessels identified before randomization according to angiography and operator judgment, as per standard of care.
μFR will be analyzed off-line by the core lab and will not be available to the operator.
|
staged PCI of all NCVs will be performed as per standard of care
|
|
Experimental: Group B - μFR based-PCI
μFR will be analyzed off-line by the core lab.
Coronary revascularization will be deferred if the μFR > 0.80 in all the non-culprit vessels identified before randomization.
If μFR ≤ 0.80 in at least one non-culprit vessels identified before randomization, patients will undergo a staged PCI.
Operators remain blinded to μFR values, and treatment of vessels is based on angiography only.
|
staged PCI will be deferred if the μFR > 0.80 in all the NCVs or performed if the μFR is ≤ 0.80 in at least one NCVs
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Primary efficacy endpoint
Prazo: Periprocedural
|
Number of stents implanted and number of procedures
|
Periprocedural
|
|
Primary safety endpoint
Prazo: 1 year
|
MACE (major adverse cardiovascular event) defined as the composite of all-cause mortality, non-culprit vessel unplanned revascularization, non-fatal myocardial infarction (defined according to the Fourth Universal Definition of Myocardial Infarction, including procedural MI and spontaneous MI)
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Inappropriate revascularization
Prazo: Periprocedural
|
Inappropriate revascularization according to μFR value
|
Periprocedural
|
|
Change in clinical decision making
Prazo: Periprocedural
|
Change in clinical decision making about revascularization strategy from intended PCI to medical therapy
|
Periprocedural
|
|
μFR reproducibility
Prazo: Periprocedural
|
Test-re-test repeatability of μFR
|
Periprocedural
|
|
Length of stay
Prazo: Periprocedural
|
Duration of hospitalization
|
Periprocedural
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- Rif. 8306, Prot. 0284/2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Angiography-guided PCI
-
Aga Khan UniversityAinda não está recrutando
-
Clinica Universidad de Navarra, Universidad de...Ainda não está recrutandoCâncer de próstata
-
Abbott Medical DevicesRetiradoInsuficiência cardíacaEstados Unidos
-
Assiut UniversityAinda não está recrutandoDerivação Ventriculoperitoneal | Trans Fontanelle EUA | Hidrocefalia Congênita
-
Xijing HospitalInscrevendo-se por convite
-
IsalaAbbottRecrutamentoRevascularização Coronária Percutânea | Lesão Coronária ComplexaHolanda
-
Mohammed Gaber SaadAtivo, não recrutandoVia Aérea DifícilEgito
-
Charite University, Berlin, GermanyConcluídoDoença Cardíaca IsquêmicaAlemanha
-
Walter Reed Army Medical CenterConcluído
-
Heinrich-Heine University, DuesseldorfPhilips Medical SystemsDesconhecidoDoença cardíacaAlemanha