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Atrial Fibrillation Detected by Continuous ECG Monitoring (LOOP) 6000

Completado
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT02036450 (LOOP) fue un estudio intervencionista para Fibrilación auricular, Accidente cerebrovascular, Hipertensión, Diabetes. Su estado actual es: completado. El estudio se inició el 1 de enero de 2014, con el objetivo de reclutar a 6000 participantes. Dirigido por Rigshospitalet, Denmark, la fecha de finalización prevista fue el 1 de marzo de 2021. Los datos se actualizaron por última vez en ClinicalTrials.gov el 10 de marzo de 2021.
Resumen
The LOOP study aims to determine whether screening for atrial fibrillation (AF) with implantable loop recorder and initiation of oral anticoagulation (OAC) if AF is detected will reduce the risk of stroke and systemic arterial embolism in patients with risk factors for stroke.
Descripción detallada
Background:

Ischemic stroke is an increasing health problem world-wide (Heidenreich PA, et al. Circulation 2011; PMID 21262990). At least 20% of ischemic strokes are attributable to atrial fibrillation (AF) (Marini C, et al. Stroke J Cereb Circ 2005; PMID 15879330). Another 30% are so-called cryptogenic, possibly related to undiagnosed AF (Brachmann J, et al. Circ Arrhythm Electrophysiol 2015; PMID 26763225). In app...

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Título oficial

Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals.

Condiciones médicas
Fibrilación auricularAccidente cerebrovascularHipertensiónDiabetes
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • LOOP
  • H-4-2013-025
  • 13-135225 (Otra financiación) (Danish Strategic Research Council)
Número del NCT
NCT02036450
Inicio del estudio (real)
2014-01
Última actualización
2021-03-10
Fecha de finalización (estimada)
2021-03
Inscripción (prevista)
6000
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Completado
Palabras clave
atrial fibrillation
cardiac arrhythmia
stroke
implantable loop recorder
bleeding
anticoagulation
hypertension
diabetes
heart failure
mortality
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalILR group
Receive implantable loop recorder (ILR, Medtronic Reveal LINQ(TM)) with continuous monitoring, and will be followed by daily automated remote transmissions. Study visits are scheduled annually until the 4th visit, and furthermore, endpoints are collected via lookup in medical records and registries on at least an annual basis until the finalization of the trial.
Implantable loop recorder (Medtronic Reveal LINQ(TM))
The patients in the experimental arm receive an implantable loop recorder (Medtronic Reveal LINQ(TM)) with continuous monitoring, and are followed by daily automated remote transmissions. New arrhythmia episodes are reviewed daily by an experienced medical doctor. If AF lasting ≥6 minutes is detected and confirmed by at least two senior cardiologists, OAC is initiated. Decision about specific type of OAC, and possibl...Mostrar más
Sin intervenciónControl group
Followed according to standard care, i.e. by their general practitioner. Study visits are scheduled at inclusion and after 3 years. Furthermore, the participants are contacted by telephone after 1 and 2 years of follow-up, and endpoints are collected via lookup in medical records and registries on at least an annual basis until the finalization of the trial.
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Time to adjudicated stroke or systemic arterial embolism
Time to the first of one of the components of the combined primary endpoint * adjudicated stroke, or * adjudicated systemic arterial embolism
At the completion of the event-driven trial, expected 4 years
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Time to adjudicated ischemic stroke/transient ischemic attack/systemic arterial embolism
Time to the first of one of the components of the combined endpoint * adjudicated ischemic stroke, or * adjudicated transient ischemic attack, or * adjudicated systemic arterial embolism
At the completion of the event-driven trial, expected 4 years
Time to adjudicated stroke, or systemic arterial embolism, or cardiovascular death
Time to the first of one of the components of the combined endpoint * adjudicated stroke, or * adjudicated systemic arterial embolism, or * adjudicated cardiovascular death
At the completion of the event-driven trial, expected 4 years
Time to adjudicated cardiovascular death
At the completion of the event-driven trial, expected 4 years
Time to death by any cause
At the completion of the event-driven trial, expected 4 years
Criterios de elegibilidad

Criterios de edad
Adulto mayor
Edad mínima
70 Years
Criterios de sexo
Todos

  • Age 70-90 years, and

  • Previously diagnosed with ≥1 of:

    • Diabetes mellitus (type 1 or type 2, with or without medical therapy)
    • Hypertension (with or without medical therapy)
    • Heart failure
    • Previous diagnosed stroke (previous transient ischemic attack is not considered an inclusion criterion)

  • History of atrial fibrillation or flutter irrespective of type
  • Cardiac pacemaker or defibrillator (with or without re-synchronization therapy)
  • Contraindication to oral anticoagulation therapy
  • Anticoagulation therapy; vitamin K antagonists, direct oral anticoagulants, or (low-molecular) heparins. Therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered an exclusion criterion
  • Renal failure treated with permanent dialysis
  • Uncorrected congenital heart disease, or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, or constrictive pericarditis.
  • On a waiting list for major surgery (cardiac, thoracic or abdominal)
  • Cardiac or thoracic surgery has been performed within 3 months from inclusion
  • Any major organ transplant (e.g. lung, liver, heart, or kidney)
  • Cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator)
  • Life-expectancy shorter than 6 months
  • Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection
  • Recent (within 3 months) history of alcohol or drug abuse based on self-reporting
  • Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study
  • Unwillingness to participate or patient does not understand Danish language
Rigshospitalet, Denmark logoRigshospitalet, Denmark
  • 🏥Bispebjerg Hospi...
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Parte responsable del estudio
Jesper Hastrup Svendsen, Investigador principal, Professor, MD, DMSc, FESC, Rigshospitalet, Denmark
No hay datos de contacto.
1 Centros del estudio en 1 países
Rigshospitalet, Copenhagen, Denmark