[Prueba de dispositivo que no está aprobado o aprobado por la FDA de EE. UU.] (CANDLE-AF)
Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Daegu, Corea del Sur
- Daegu Catholic University Medical Center
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Seoul, Corea del Sur, 02447
- Kyung Hee University Hospital
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Seoul, Corea del Sur, 06273
- Yonsei University Health System, Severance Hospital
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Seoul
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Gangseo, Seoul, Corea del Sur, 07985
- Ewha Womans University Seoul Hospital
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Seongdong, Seoul, Corea del Sur, 04763
- Hanyang University Seoul Hospital
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Seoul, Seoul, Corea del Sur, 08308
- Korea University Guro Hospital
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Yangcheon, Seoul, Corea del Sur, 07985
- Ewha Womans University Mokdong Hospital
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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:
- Age 18 years or older
- Ischemic stroke or transient ischemic attack with no identified cause (cryptogenic) after standard etiologic evaluation, admitted to the neurology department of a participating center
- No history of atrial fibrillation and no atrial fibrillation on the admission ECG or on continuous in-hospital telemetry
- Informed of implantable cardiac monitoring according to guidelines and declined it
- Written informed consent
Exclusion Criteria:
- Identified etiology of the stroke or transient ischemic attack
- Known or documented atrial fibrillation, including prior atrial fibrillation with restored sinus rhythm
- Pacemaker, implantable cardioverter-defibrillator, or other implanted electrical device
- Unable to use the smartphone-based recorder alone or with the help of others
- Pregnancy or lactation - Skin cancer, rash, skin disease, keloid, or injury at the patch site (current or history)
- Life expectancy less than 1 year
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- 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: Conventional Holter Monitoring Group
Physician-directed standard care, including at least one 24- to 72-hour Holter recording; further rhythm monitoring during the 12-month follow-up at the treating physician's discretion. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
Otros nombres:
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Experimental: Discontinuous Monitoring Group
Standard care plus twice-daily 30-second single-lead ECG recordings with a smartphone-based handheld recorder (KardiaMobile, AliveCor) for 12 months, transmitted through the smartphone application to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
Otros nombres:
Twice-daily 30-second handheld single-lead ECG recording for 12 months.
Otros nombres:
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Experimental: Single-lead Continuous Patch Group
Standard care plus continuous 72-hour single-lead adhesive patch ECG monitoring (mobiCARE-MC100, Seers Technology) at 1, 3, 6, and 12 months after enrollment, transmitted to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
Otros nombres:
72-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions)
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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Detection of atrial fibrillation lasting 30 seconds or longer
Periodo de tiempo: Within 12 months after randomization
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First detection of AF lasting at least 30 seconds on any ECG recording (assigned device, Holter, 12-lead ECG, or clinical recording), confirmed by physician review |
Within 12 months after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recurrent ischemic stroke or transient ischemic attack
Periodo de tiempo: Within 12 months after randomization
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Within 12 months after randomization
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Major adverse cardiovascular and cerebrovascular events (MACCE)
Periodo de tiempo: Within 12 months after randomization
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composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death |
Within 12 months after randomization
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Initiation of oral anticoagulation following AF detection
Periodo de tiempo: Within 12 months after randomization
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Initiation of oral anticoagulation following AF detection |
Within 12 months after randomization
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All-cause readmission
Periodo de tiempo: Within 12 months after randomization
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Within 12 months after randomization
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All-cause death
Periodo de tiempo: Within 12 months after randomization
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All-cause death |
Within 12 months after randomization
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Major bleeding
Periodo de tiempo: Within 12 months after randomization
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Fatal or overt bleeding with a drop in hemoglobin level of at least 2 g/dL or requiring transfusion of at least 2 units packed blood cells, or critical anatomical site hemorrhage (e.g., intracranial, retroperitoneal) |
Within 12 months after randomization
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Junbeom Park, M.D., PhD., Ewha Womans University Mokdong Hospital
- Investigador principal: Tae-Jin Song, MD, Ewha Womans University Seoul Hospital
- Investigador principal: Dong-Hyeok Kim, MD, Ewha Womans University Seoul Hospital
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 (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
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Arritmias Cardiacas
- Isquemia cerebral
- Carrera
- Condiciones Patológicas, Signos y Síntomas
- Accidente cerebrovascular isquémico
- Ataque Isquémico, Transitorio
- Fibrilación auricular
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Técnicas de diagnóstico, cardiovascular
- Pruebas de funciones cardíacas
- Electrodiagnóstico
- Monitoreo, fisiológico
- Electrocardiografía
- Monitoreo, ambulatorio
- Electrocardiografía, ambulatoria
Otros números de identificación del estudio
- CANDLE-AF Trial
- NRF-2022R1A2C1093352 (Otro número de subvención/financiamiento: National Research Foundation of Korea)
- RS-2020-KD000234 (Otro número de subvención/financiamiento: Korea Medical Device Development Fund)
- RS-2025-25459963 (Otro número de subvención/financiamiento: Korea Health Industry Development Institute)
- KCT0005592 (Identificador de registro: CRIS)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data underlying the published results, a data dictionary defining each field, and the statistical analysis code will be made available to qualified investigators.
Marco de tiempo para compartir IPD
Beginning 12 months after publication of the primary results, with no end date
Criterios de acceso compartido de IPD
Requests with a methodologically sound proposal should be directed to the corresponding author (parkjb@ewha.ac.kr). Access requires approval by the institutional review board of Ewha Womans University Medical Center and a signed data access agreement; data will be shared only for analyses within the scope of the informed consent.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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.
producto fabricado y exportado desde los EE. UU.
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