Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment (CT-FFR-CHINA)
Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment (CT-FFR-CHINA)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Numerous studies have demonstrated high diagnostic accuracy of CCTA to detect and exclude coronary artery disease (CAD). One main limitation of CCTA, however, is a tendency to overestimate the severity of coronary artery stenosis against invasive coronary angiography (ICA). On the other hand, FFR, invasively measured under ICA, is recognized as the current gold standard in determination of coronary artery lesions due to improved long-term clinical outcomes when revascularization is guided by FFR instead of ICA. Moreover, prior studies indicated unreliable relationships between detection of obstructive anatomic coronary artery stenoses defined by CCTA and hemodynamically significant lesions by invasive fractional flow reserve (FFR).
Recent advances in artificial intelligence and computational modeling techniques now permit construction of a 3-dimensional model of coronary arteries visible from CCTA images and computation of FFR anywhere in the entire 3D model noninvasively. Several prior prospective, multicenter studies have reported promising results for the diagnostic performance of CT-FFR using invasive FFR as the reference standard. However, the diagnostic performance of CT-FFR in Chinese population is not clear. Therefore, we hereby designed the CT-FFR-CHINA study to determine the hemodynamically significant lesions, exclusively in Chinese subjects. It is a prospective and multi-center trial with a total of 326 subjects enrolled at 4 Chinese centers.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana
- Fuwai Hospital
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Beijing, Beijing, Porcelana
- Chao-Yang Hospital
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Shandong
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Jinan, Shandong, Porcelana
- Qi Lu Hospital, Shan Dong University
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Zhejiang
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Hangzhou, Zhejiang, Porcelana
- Sir Run Run Shaw Hospital, Zhe Jiang University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
General Criteria:
- Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI
- Age > 18 years
- Able to provide signed informed consent
CCTA inclusion criteria:
- At least one stenosis with diameter stenosis of 30%-90% by visual estimate
- Reference vessel size > 2 mm in stenotic segment by visual estimate
Exclusion Criteria:
General Criteria:
- Ineligible for diagnostic intervention or FFR examination
- Myocardial infarction within 72 hours
- Severe heart failure (NYHA≥III)
- S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
- Allergy to contrast agent or adenosine
- Factors that might substantially impact the CCTA image quality, e.g, frequent atrial premature beat or atrial fibrillation
Angiographic exclusion criteria:
- The interrogated stenosis is caused by myocardial bridge
- Ostial lesions less than 3 mm to the aorta
- Poor angiographic image quality precluding contour detection
- Severe overlap of stenotic segments
- Severe tortuosity of target vessel
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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sensitivity and specificity of CT-FFR compared with CCTA
Periodo de tiempo: 7days
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In comparison to CCTA, sensitivity and specificity of CT-FFR determine whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard.
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7days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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accuracy, positive predictive value, negative predictive value of CT-FFR compared with CCTA
Periodo de tiempo: 7days
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In comparison to CCTA, accuracy, positive predictive value, negative predictive value of CT-FFR to determine whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard
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7days
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the area under the receiver operating characteristic curve of CT-FFR compared with CCTA
Periodo de tiempo: 7days
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In comparison to CCTA, the area under the receiver operating characteristic curve of CT-FFR in determining whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard
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7days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Gao Y, Zhao N, Song L, Hu H, Jiang T, Chen W, Zhang F, Dou K, Mu C, Yang W, Fu G, Xu L, Li D, Fan L, An Y, Wang Y, Li W, Xu B, Lu B. Diagnostic Performance of CT FFR With a New Parameter Optimized Computational Fluid Dynamics Algorithm From the CT-FFR-CHINA Trial: Characteristic Analysis of Gray Zone Lesions and Misdiagnosed Lesions. Front Cardiovasc Med. 2022 Mar 22;9:819460. doi: 10.3389/fcvm.2022.819460. eCollection 2022.
- Gao Y, Zhao N, Song L, Hu F, Mu C, Gao L, Cui J, Yin D, Yang W, Xu B, Lu B. Diastolic versus systolic coronary computed tomography angiography derived fractional flow reserve for the identification of lesion-specific ischemia. Eur J Radiol. 2022 Feb;147:110098. doi: 10.1016/j.ejrad.2021.110098. Epub 2021 Dec 14.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- CNCCD
Información sobre medicamentos y dispositivos, documentos del estudio
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