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O estudo clínico NCT02036450 (LOOP) para Fibrilação atrial, Acidente vascular cerebral, Hipertensão, Diabetes está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Atrial Fibrillation Detected by Continuous ECG Monitoring (LOOP) 6.000
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT02036450 (LOOP) foi um estudo intervencionista para Fibrilação atrial, Acidente vascular cerebral, Hipertensão, Diabetes. Seu status atual é: concluído. O estudo começou em 1 de janeiro de 2014 e incluiu 6.000 participantes. Coordenado por Rigshospitalet, Denmark e foi concluído em 1 de março de 2021. Essas informações foram atualizadas no ClinicalTrials.gov em 10 de março de 2021.
Resumo
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.
Descrição detalhada
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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Atrial Fibrillation Detected by Continuous ECG Monitoring Using Implantable Loop Recorder to Prevent Stroke in High-risk Individuals.
Condições médicas
Fibrilação atrialAcidente vascular cerebralHipertensãoDiabetesPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- LOOP
- H-4-2013-025
- 13-135225 (Outro financiamento) (Danish Strategic Research Council)
Número NCT
Data de início (real)
2014-01
Última atualização postada
2021-03-10
Data de conclusão (estimada)
2021-03
Inscrição (estimada)
6.000
Tipo de estudo
Intervencionista
FASE
N/A
Status
Concluído
Palavras-chave
atrial fibrillation
cardiac arrhythmia
stroke
implantable loop recorder
bleeding
anticoagulation
hypertension
diabetes
heart failure
mortality
cardiac arrhythmia
stroke
implantable loop recorder
bleeding
anticoagulation
hypertension
diabetes
heart failure
mortality
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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 mais |
Nenhuma intervençãoControl 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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Idoso
Idade mínima
70 Years
Sexos elegíveis
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- 🏥Bispebjerg Hospi...
Responsável pelo estudo
Jesper Hastrup Svendsen, Investigador principal, Professor, MD, DMSc, FESC, Rigshospitalet, Denmark
Sem dados de contato.
1 Locais do estudo em 1 países
Rigshospitalet, Copenhagen, Denmark