- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07628270
Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, and Fractional Flow Reserve Derived by Computed Tomography (FAST-CABG)
FAST-CABG: Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, (CCTA) and Fractional Flow Reserve Derived by Computed Tomography (FFRCT)
Descripción general del estudio
Estado
Descripción detallada
The present study is a observational, prospective, multicenter European study aims to explore in the population of FAST-TRACK CABG the patient-reported outcome measures (by Seattle Angina Questionnaire SAQ) as well as major adverse cerebral and cardiovascular events (MACCE) in FAST TRACK CABG population. Patients meeting all inclusion criteria will be asked to sign an informed consent document.
Clinical outcomes will be collected using Seattle Angina Questionnaire (SAQ). Will be also collected the New York Heart Association (NYHA); MACCE and All-cause death, components of MACCE and cardiovascular hospitalization.
During this visit, the value of Lp (a), which was previously dosed according to the guidelines, will also be recorded
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gianluca Pontone, MD
- Número de teléfono: +39 0258002574
- Correo electrónico: gianluca.pontone@cardiologicomonzino.it
Copia de seguridad de contactos de estudio
- Nombre: Saima Mushtaq, MD
- Número de teléfono: +39 0258002679
- Correo electrónico: saima.mushtaq@cardiologicomonzino.it
Ubicaciones de estudio
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MI
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Milan, MI, Italia, 20131
- Reclutamiento
- Centro Cardiologico Monzino; IRCCS
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Contacto:
- Chiara Centenaro
- Número de teléfono: +39 0258002031
- Correo electrónico: chiara.centenaro@cardiologicomonzino.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients who have analyzable pre-CABG CCTA imaging and received a successful CCTA-guided plus FFRCT CABG procedure.
- Patient with known level of Lp(a) or with possibility to perform the test
- Patent able to provide written informed consent as approved by the Ethical Committee
Exclusion Criteria:
- Patients without pre-CABG CCTA imaging or those with who did not receive surgical revascularization.
- Current treatment with lipoprotein apheresis
- Patients who refuse to receive clinical follow-up
- Unable to give Informed Consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Prospective Cohort
Patients enrolled in a prior clinical trial undergoing follow-up for the assessment of patient-reported outcomes (SAQ), MACCE, and biomarker correlations, including serum lipoprotein(a) levels
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient-Reported Outcomes assessed by Seattle Angina Questionnaire (SAQ)
Periodo de tiempo: May 2026
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The primary aim of this study is to explore in the population of FAST-TRACK CABG the patient-reported outcome measures (by Seattle Angina Questionnaire SAQ) in FAST TRACK CABG population.
In coronary artery disease, the Seattle Angina Questionnaire (SAQ) has emerged as the most commonly used measure of disease-specific health status to quantify patients' symptoms of angina and the degree to which their angina impacts their function and quality of life.
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May 2026
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Major Adverse Cerebral and Cardiovascular Events
Periodo de tiempo: May 2026
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Occurrence of major adverse cerebral and cardiovascular events, including all-cause death, myocardial infarction, stroke, and repeat revascularization.
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May 2026
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Correlation of Lipoprotein(a) with Cardiovascular Outcomes in Complex Coronary Artery Disease
Periodo de tiempo: May 2026
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The secondary objectives of this study are to evaluate if serum Lp(a) levels improve the predictive capacity of imaging biomarkers in predicting MACCE; to evaluate the correlation between serum Lp(a) levels and CCTA-derived total plaque volume, high risk plaque features, in patients with complex three-vessel or left main coronary artery disease (CAD) participating in the FASTTRACK CABG Trial.
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May 2026
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- L2-347
Información sobre medicamentos y dispositivos, documentos del estudio
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