Chest CT With Iterative Reconstruction as an Alternative to Conventional Chest X-ray Prior to Heart Surgery (CRICKET)
Ultra Low-dose Chest CT With Iterative Reconstructions as an Alternative to Conventional Chest X-ray Prior to Heart Surgery
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
During heart surgery the aorta is clamped to initiate cardiopulmonary bypass. This may crush aortic calcifications causing them to embolize to the brain causing a stroke which is a devastating complication for the patient. A chest X-ray is routinely performed prior to heart surgery. It provides no information about aortic calcification. Imaging by a chest computed tomography (CT) scan provides detailed information on aortic calcification but has higher radiation exposure and thus is not used routinely. Recently iterative reconstruction (IR) techniques have become available that allow chest CT to be performed at markedly reduced dose with retained image quality. Routine use of low dose chest CT with IR prior to heart surgery may identify patients with a severely calcified aorta in which the surgery may subsequently adapted to minimize or avoid aortic manipulation which may reduce stroke rate.
In this multicenter randomized controlled clinical trial the effect of preoperative chest CT on postoperative stroke is investigated. In total 1724 patients will be included of whom 862 patients will receive an additional CT to standard care and 862 patients will receive routine care.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Budapest, Hungría
- Heart and Vascular Center Semmelweis University
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Rotterdam, Países Bajos
- Erasmus Medical Center
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Utrecht, Países Bajos, 3508GA
- University Medical Center Utrecht
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years old or older
- Scheduled to undergo heart surgery
- Provide written informed consent
Exclusion Criteria:
- Patient not meeting inclusion criteria
- Pregnant women
- Scheduled to undergo transcatheter aortic valve insertion procedure (since these patients receive a standard preoperative CT)
- Chest or cardiac CT in the past three months
- Emergency surgery
- Concomitant or previous participation in a study that prohibits the patient from participating in a study that exposed the patient to radiation
- Unwillingness to be informed about unrequested findings on the CT scan
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
Routine clinical care (which includes a conventional chest X-ray).
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Experimental: CT scan
Routine clinical care, which includes a chest x-ray, with an additional ultra low-dose non contrast enhanced chest CT with IR (performed preoperatively).
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The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Postoperative stroke
Periodo de tiempo: Participants will be followed for the duration of hospital stay, an expected average of 5 days
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Percentage of patients suffering from in-hospital postoperative stroke (central neurological defect that either recovers spontaneously or is permanent) after heart surgery.
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Participants will be followed for the duration of hospital stay, an expected average of 5 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Altered surgical approach
Periodo de tiempo: The surgery will take place the day after hospital administration.
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Percentage of patients in which the surgical approach is altered based on information derived from the preoperative chest CT.
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The surgery will take place the day after hospital administration.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ricardo PJ Budde, MD, PhD, Erasmus MC Rotterdam
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- NL47293.041.13
- 837001403 (Otro número de subvención/financiamiento: ZonMw)
Plan de datos de participantes individuales (IPD)
Datos del estudio/Documentos
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Protocolo de estudio
Comentarios de información: Ultra low-dose chest ct with iterative reconstructions as an alternative to conventional chest x-ray prior to heart surgery (CRICKET study): Rationale and design of a multicenter randomized trial.
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