- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07819344
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
Molecular Imaging and Deep Phenotyping to Identify Predictors of AS Disease Activity and Progression
Descripción general del estudio
Estado
Descripción detallada
Structural imaging modalities, such as echocardiography (echo) and computed tomography (CT), measure the structural consequences of aortic valvular calcification and have proven invaluable for grading AS severity. However, these techniques cannot capture the dynamic microcalcification processes that drive the underlying disease and have proven insufficient for predicting AS progression. In contrast, molecular imaging with 18F-NaF positron emission tomography/computed tomography (18F-NaF PET/CT) is the gold-standard method for noninvasively measuring the central pathophysiological process driving the progression of AS. This imaging approach uses 18F-sodium fluoride, a tracer that binds preferentially to hydroxyapatite in regions of developing microcalcification. This enables quantification of microcalcification activity (which precedes visible macrocalcification) and provides insights into the underlying disease activity that drives AS progression. Notably, optimized protocols for 18F-NaF PET/CT yield a reproducible biomarker to track disease activity and predict progression. Furthermore, recent advances in PET technology (such as total-body PET scanners) have improved sensitivity by 10- to 40-fold, further enhancing the quantification of the microcalcification rate underlying AS progression.
Overall, the assessment of microcalcification activity shifts the focus from static anatomical assessments to measurement of the dynamic pathological process driving AS progression. However, while 18F-NaF PET/CT is unsuitable for routine clinical use (because it is costly and currently limited to research applications), it can be effectively leveraged to train predictive models and deploy them as clinical calculators to estimate the rate of microcalcification from readily available biomarker data. The resulting clinical models and calculators could greatly enhance clinical care by identifying patients at risk of rapid progression, refining risk stratification and prognostic accuracy, and opening avenues for personalized monitoring and treatment in calcific AS.
The overarching goal of this Clinical Imaging Study is to develop novel predictive models and clinical calculators that capture AS microcalcification activity and forecast the risk of progressive aortic valve stenosis among participants with mild-to-moderate AS. The investigators will achieve this by performing advanced multimodality imaging, including 18F-NaF PET/CT, to quantify microcalcification activity in deeply phenotyped patients using clinical, imaging, and blood plasma biomarkers. Computational approaches, including AI tools, will identify optimal combinations of imaging and non-imaging predictors of microcalcification activity. The investigators will then develop accessible clinical calculators and test the hypothesis that these models and calculators enhance identification of rapid progressors through cross-validation and external validation in the Population Project cohort (which undergoes identical biomarker phenotyping).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmed Tawakol A Director, MD
- Número de teléfono: 3699 6177262000
- Correo electrónico: atawakol@mgh.harvard.edu
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:
- Males and females
- aged 18 years or older
- mild to moderate calcific Aortic Stenosis (as defined by standard echocardiographic criteria)
Exclusion Criteria:
- Bicuspid Aortic Stenosis
- pregnancy
- cognitive disabilities that impair the ability to comply with instructions or provide informed consent
- any other medical condition that may undermine participation
- weight >300 lbs
- severe claustrophobia
- Pregnancy
- subjects who have had significant radiation exposure as part of research (>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12 months
- Individuals with renal dysfunction (eGFR<55) or a history of allergic reaction to iodinated contrast will not receive the iodinated contrast.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Individuals with mild or moderate aortic stenosis
Mild or moderate aortic stenosis noted on imaging and not expected to undergo treatment of the aortic valve over the next year.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
rate of AS progression
Periodo de tiempo: One year
|
change of echo- and CT-derived AS measures
|
One year
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
Enlaces Útiles
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
- Enfermedades cardiovasculares
- Enfermedades cardíacas
- Enfermedades metabólicas
- Enfermedades de las válvulas cardíacas
- Obstrucción del flujo de salida ventricular
- Trastornos del metabolismo del calcio
- Enfermedades Nutricionales y Metabólicas
- Enfermedad de la válvula aórtica
- Estenosis de la válvula aórtica
- Calcinosis
Otros números de identificación del estudio
- 2026p001100
- 26SFRNPVHD1623048 (Otro número de subvención/financiamiento: American Heart Association)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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