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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emanuele Barbato, MD, PhD
- Número de teléfono: +39 06 3377 6115
- Correo electrónico: emanuele.barbato@uniroma1.it
Copia de seguridad de contactos de estudio
- Nombre: Emanuele Gallinoro, MD, PhD
- Número de teléfono: +39 06 3377 5005
- Correo electrónico: egallinoro@gmail.com
Ubicaciones de estudio
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RM
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Roma, RM, Italia, 00189
- Azienda ospedaliero - universitaria Sant'Andrea
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Contacto:
- Emanuele Barbato, MD, PhD
- Número de teléfono: +39 06 3377 6115
- Correo electrónico: emanuele.barbato@uniroma1.it
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Contacto:
- Emanuele Gallinoro, MD, PhD
- Número de teléfono: +39 06 3377 5005
- Correo electrónico: egallinoro@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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staged PCI of all NCVs will be performed as per standard of care
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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.
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Primary efficacy endpoint
Periodo de tiempo: Periprocedural
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Number of stents implanted and number of procedures
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Periprocedural
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Primary safety endpoint
Periodo de tiempo: 1 year
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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)
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Inappropriate revascularization
Periodo de tiempo: Periprocedural
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Inappropriate revascularization according to μFR value
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Periprocedural
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Change in clinical decision making
Periodo de tiempo: Periprocedural
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Change in clinical decision making about revascularization strategy from intended PCI to medical therapy
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Periprocedural
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μFR reproducibility
Periodo de tiempo: Periprocedural
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Test-re-test repeatability of μFR
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Periprocedural
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Length of stay
Periodo de tiempo: Periprocedural
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Duration of hospitalization
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Periprocedural
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Rif. 8306, Prot. 0284/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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