- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01025947
"Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder (ILR)" (CRYPTONITE)
Observational Study on Cryptogenic Stroke and Atrial Fibrillation Detection Through Implantable Loop Recorder
STUDY TYPE:
Prospective, national , multicenter, and observational study.
OBJECTIVE:
To assess the incidence of AF in patients with cryptogenic stroke who have implanted an AF detection device during a period of 2 years.
DEVICE:
Reveal XT 9529 (SQDM)
SAMPLE SIZE AND STUDY DURATION:
100 patients enrolled which will be followed during a period of 2 years.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Murcia, España, 30120
- Reclutamiento
- Hospital Universitario Virgen de la Arrixaca
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Investigador principal:
- Arcadio García-Alberola, MD, PhD
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Investigador principal:
- Ana Morales, MD
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Valencia, España, 46010
- Reclutamiento
- Hospital Clinico Universitario de Valencia
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Investigador principal:
- Ricardo Ruiz-Granell, MD, PhD
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Investigador principal:
- Alejandro Ponz, MD
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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:
All patients included must meet one of these two conditions:
- Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging.
- First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria
All patients must meet all of the following:
- The patient has been implanted an ILR within 30 days after qualifying event
- Age between 45-85 years
- No stenosis >50% in any arterial vessel corresponding to the affected territory
- Normal Echocardiography
- Normal 24 hours EKG Holter recording
- Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography)
- Acceptance and signature of Patient Informed Consent.
Exclusion Criteria:
All patients included cannot meet any of the following conditions:
- Recurrent stroke or TIA
- Stroke or TIA with determined etiology according to TOAST criteria.
- Anticoagulation indication at the time of enrollment in the study.
- Total contraindication for anticoagulation therapy
- Atrial fibrillation detection prior to enrollment
- Severe cognitive impairment or dementia
- Patient unable to be followed up
- Patients enrolled in another clinical trial
- Patients with life expectancy of less than 1 year
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Study group
Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
First AF episode detected by the implantable loop recorder in patients that had a cryptogenic stroke. An AF episode will be considered an AF episode that lasts at least 2 minutes.
Periodo de tiempo: Patients will be followed up during two years, regardless of reaching or not the primary endpoint.
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Patients will be followed up during two years, regardless of reaching or not the primary endpoint.
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
All subsequent AF episodes detected by the ILR after primary outcome (AF burden)
Periodo de tiempo: Patients will be followed up during two years
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Patients will be followed up during two years
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AF episodes detected by external monitoring
Periodo de tiempo: Patients will be followed up during two years
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Patients will be followed up during two years
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Presence of stroke, recurrent TIA, or silent infarction in neuroimaging
Periodo de tiempo: Patients will be followed up during two years
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Patients will be followed up during two years
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Changes in anticoagulant therapy
Periodo de tiempo: Patients will be followed up during two years
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Patients will be followed up during two years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ricardo Ruiz-Granell, MD, Phd, Hospital Clinico Universitario de Valencia
- Silla de estudio: Arcadio Garcia-Alberola, MD, PhD, Hospital Universitario Virgen de la Arrixaca
- Silla de estudio: Ana Morales, MD, Hospital Universitario Virgen de la Arrixaca
- Silla de estudio: Alejandro Ponz, MD, Hospital Clinico Universitario de Valencia
Publicaciones y enlaces útiles
Publicaciones Generales
- Carandang R, Seshadri S, Beiser A, Kelly-Hayes M, Kase CS, Kannel WB, Wolf PA. Trends in incidence, lifetime risk, severity, and 30-day mortality of stroke over the past 50 years. JAMA. 2006 Dec 27;296(24):2939-46. doi: 10.1001/jama.296.24.2939.
- Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.
- Solano A, Menozzi C, Maggi R, Donateo P, Bottoni N, Lolli G, Tomasi C, Croci F, Oddone D, Puggioni E, Brignole M. Incidence, diagnostic yield and safety of the implantable loop-recorder to detect the mechanism of syncope in patients with and without structural heart disease. Eur Heart J. 2004 Jul;25(13):1116-9. doi: 10.1016/j.ehj.2004.05.013.
- Rosamond W, Flegal K, Friday G, Furie K, Go A, Greenlund K, Haase N, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell CJ, Roger V, Rumsfeld J, Sorlie P, Steinberger J, Thom T, Wasserthiel-Smoller S, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2007 Feb 6;115(5):e69-171. doi: 10.1161/CIRCULATIONAHA.106.179918. Epub 2006 Dec 28. No abstract available. Erratum In: Circulation. 2007 Feb 6;115(5):e172. Circulation. 2010 Jul 6;122(1):e9. Kissela, Bret [corrected to Kissela, Brett].
- Jabaudon D, Sztajzel J, Sievert K, Landis T, Sztajzel R. Usefulness of ambulatory 7-day ECG monitoring for the detection of atrial fibrillation and flutter after acute stroke and transient ischemic attack. Stroke. 2004 Jul;35(7):1647-51. doi: 10.1161/01.STR.0000131269.69502.d9. Epub 2004 May 20.
- Adams HP Jr, Davis PH, Leira EC, Chang KC, Bendixen BH, Clarke WR, Woolson RF, Hansen MD. Baseline NIH Stroke Scale score strongly predicts outcome after stroke: A report of the Trial of Org 10172 in Acute Stroke Treatment (TOAST). Neurology. 1999 Jul 13;53(1):126-31. doi: 10.1212/wnl.53.1.126.
- Sacco RL, Ellenberg JH, Mohr JP, Tatemichi TK, Hier DB, Price TR, Wolf PA. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. 1989 Apr;25(4):382-90. doi: 10.1002/ana.410250410.
- Douen AG, Pageau N, Medic S. Serial electrocardiographic assessments significantly improve detection of atrial fibrillation 2.6-fold in patients with acute stroke. Stroke. 2008 Feb;39(2):480-2. doi: 10.1161/STROKEAHA.107.492595. Epub 2008 Jan 3.
- Liao J, Khalid Z, Scallan C, Morillo C, O'Donnell M. Noninvasive cardiac monitoring for detecting paroxysmal atrial fibrillation or flutter after acute ischemic stroke: a systematic review. Stroke. 2007 Nov;38(11):2935-40. doi: 10.1161/STROKEAHA.106.478685. Epub 2007 Sep 27.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- Procesos Patológicos
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Arritmias Cardiacas
- Carrera
- Accidente cerebrovascular isquémico
- Fibrilación auricular
Otros números de identificación del estudio
- HCUV
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