A Clinical Trial Screening for Atrial Fibrillation (AF-CATCH) (AF-CATCH)
2 de noviembre de 2020 actualizado por: Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
A Randomized Clinical Trial on Atrial Fibrillation Screening by Using an Automated Electrocardiogram System in an Elderly Chinese Population
- Study name:A randomized clinical trial on atrial fibrillation screening by using an automated electrocardiogram system in an elderly Chinese population
- Rationale: Failure in the diagnosis and management of atrial fibrillation leads to high incidence of stroke and high mortality and disability. It is therefore imperative to diagnose and manage atrial fibrillation in a timely and effective fashion to prevent the complications of atrial fibrillation.
- Objective:The primary objective is to investigate whether more frequent ECG recordings and analyses with this automated ECG system (4 times/year) would significantly improve the detection of atrial fibrillation compared to a single annual ECG screen.The secondary objective is to explore whether even more frequent ECG recordings and analyses (8 times/year) would further improve the detection of atrial fibrillation.
- Study design: The present study is designed as a randomized controlled trial of parallel group (two).
- Study population: Men and women aged at least 65 years (n=7000) meet the inclusion/exclusion criteria.
- Randomization and treatment: Eligible subjects will be randomized in a 1:1 ratio into the usual and intensive screening groups with 3500 patients in each group, and within the intensive screening group in a 3:1 ratio into the intensive and more intensive subgroups with 2625 and 875 patients, respectively.
- Follow up: 1)Usual screening group: ECG recordings at baseline plus at 1 and 2 year of follow-up; three ECG recordings in total. 2)Intensive screening subgroup: ECG recordings at baseline plus quarterly during follow-up, at months 3, 6, 9, 12, 15, 18, 21 and 24; 9 ECG recordings in total. 3)More intensive screening subgroup: ECG recordings at baseline plus weekly during the first month of follow-up and quarterly afterwards, at weeks 1, 2, 3 and 4 and months 3, 6, 9, 12, 15, 18, 21 and 24; 13 ECG recordings in total.
- Sample size estimation: The number of required subject for the whole trial is 7000.
- Timeline: Start of subjects enrollment : December 2016; End of subjects enrollment : June 2017; End of study : October 2020
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
- Study name:A randomized clinical trial on atrial fibrillation screening by using an automated electrocardiogram system in an elderly Chinese population
- Rationale: The incidence of atrial fibrillation rises continuously.The main detrimental effect of atrial fibrillation is its complication of stroke.Failure in the diagnosis and management of atrial fibrillation before the incidence of stroke leads to high mortality and disability. It is therefore imperative to diagnose and manage atrial fibrillation in a timely and effective fashion and prevent the complications of atrial fibrillation, by screening followed by the use of proven therapy, such as warfarin. An automated handheld ECG system based on a smartphone has recently become available for the screening of atrial fibrillation in high risk people.However, how this system can be most effectively used for the widespread screening of atrial fibrillation remains a question that requires investigation. Moreover, while repeated recordings will have a higher yield of atrial fibrillation diagnosis [11], it is not certain what constitutes an optimum number of ECG recordings balancing cost and effectiveness. The present study was therefore designed as a randomized controlled trial to investigate whether more frequent ECG recordings and analyses with this automated ECG system would significantly improve the detection of atrial fibrillation compared to a single annual ECG screen in elderly Chinese population in the community health centre.
- Objective:The primary objective is to investigate whether more frequent ECG recordings and analyses with this automated ECG system (4 times/year) would significantly improve the detection of atrial fibrillation compared to a single annual ECG screen.The secondary objective is to explore whether even more frequent ECG recordings and analyses (8 times/year) would further improve the detection of atrial fibrillation.
- Study design: The present study is designed as a randomized controlled trial of parallel group (two)
- Study population: Men and women aged at least 65 years (n=7000) will be recruited from 5 community health centers in the city of Shanghai. Eligible patients should meet the following inclusion and exclusion criteria.Inclusion Criteria:1) Age≥65 years; 2) Absence of atrial fibrillation at baseline; 3) Willing and capable to visit the outpatient clinic on his/her own for long-term follow-up. Exclusion Criteria:1) Known persistent or paroxysmal atrial fibrillation : Sinus rhythm after pharmacological or electric cardioversion, or radiofrequency ablation;Use of anticoagulant therapy and atrial fibrillation;Use of medication for heart rate control;Untreated atrial fibrillation.2) Serious life-threatening diseases, such as, cancer, severe cardiac, cerebral, liver, kidney diseases, etc;3) Difficult for long-term follow-up visit for any reason
- Randomization and treatment: Eligible subjects will be randomized in a 1:1 ratio into the usual and intensive screening groups with 3500 patients in each group, and within the intensive screening group in a 3:1 ratio into the intensive and more intensive subgroups with 2625 and 875 patients, respectively. 1)Usual screening group: ECG recordings at baseline plus at 1 and 2 year of follow-up; three ECG recordings in total. 2)Intensive screening subgroup: ECG recordings at baseline plus quarterly during follow-up, at months 3, 6, 9,12, 15, 18, 21 and 24; 9 ECG recordings in total. 3)More intensive screening subgroup: ECG recordings at baseline plus weekly during the first month of follow-up and quarterly afterwards, at weeks 1, 2, 3 and 4 and months 3, 6, 9, 12, 15, 18, 21 and 24; 13 ECG recordings in total. The automated electrocardiogram analysis system AliveCor® Heart Monitor will be used to perform ECG recordings and analysis for the immediate diagnosis of atrial fibrillation. At one and two year of follow-up, a follow-up questionnaire will be administered and physical examinations will be performed. All detected cases of atrial fibrillation will be further evaluated with a regular 12-lead ECG, and then referred to a specialists' centre for treatment.
- Follow up: In the usual screening group, patients will be followed-up in the community health centre at baseline and at 12 and 24 months of follow-up. In the intensive screening group, patients will be followed-up at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up. In the more intensive screening subgroup, patients will be followed-up weekly in the first month of follow-up and at 3, 6, 9, 12, 15, 18, 21 and 24 months of follow-up.
- Sample size estimation: The detection rate of atrial fibrillation by a single 12-lead ECG was 2.5% in elderly people living in Shanghai Of the 2.5%, only 0.5% were aware of atrial fibrillation. The detection rate of atrial fibrillation by an ECG recording at baseline and another in 12 months could be estimated to be 2.0% in elderly people without awareness of atrial fibrillation. The primary hypothesis is that the detection rate could be improved by 50% with more frequent ECG recordings. If =0.05, power=80% and one-sided test are assumed, and a 1:1 ratio would be used to assign patients to usual and intensive ECG screening, the study will require a sample size of 3013 subjects per group. In consideration of a 15% of super-addition, approximately 3500 eligible subjects per group should be enrolled. The number of required subjects for the whole trial is 7000.
- Timeline : Enrollment rate : 1000 patients /month ; Planned publication /presentation : October 2020; Start of subjects enrollment : December 2016; End of subjects enrollment : June 2017; End of study : October 2020
- Organization: The study will be conducted in a single research center (Ruijin Hospital) with 5 community health centers. Patients will be recruited and followed up by the community health physicians in 5 community health centers, under the supervision of cardiologists from Ruijin Hospital. ECG will be recorded in each of the community health centers. Atrial fibrillation will be initially diagnosed by the software build in the smart phone. ECG will also be transmitted to a cloud platform for storage and further analysis. If atrial fibrillation is detected, a 12-lead ECG will be immediately performed for the verification and confirmation of the diagnosis of atrial fibrillation. The identified patients with atrial fibrillation will be referred to the outpatient clinic of Ruijin Hospital for management.
Tipo de estudio
De observación
Inscripción (Actual)
4348
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Shanghai, Porcelana, 200025
- Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Men and women aged at least 65 years (n=7000) will be recruited from 5 community health centers in the city of Shanghai and randomized into a group of more frequent (4 or 8) ECG recordings and analyses (n=3500) and a group of a single ECG recording and analysis during 12 months of follow-up (n=3500).
The intensive screening group will be further randomly divided into intensive (n=2625) and more intensive subgroups (n=875).
Eligible patients should meet the following inclusion and exclusion criteria.
Descripción
Inclusion Criteria:
- Age 65 years;
- Absence of atrial fibrillation at baseline;
- Willing and capable to visit the outpatient clinic on his/her own for long-term follow-up.
Exclusion Criteria:
- Known persistent or paroxysmal atrial fibrillation 1)Sinus rhythm after pharmacological or electric cardioversion, or radiofrequency ablation; 2)Use of anticoagulant therapy and atrial fibrillation; 3)Use of medication for heart rate control; 4)Untreated atrial fibrillation.
- Serious life-threatening diseases, such as, cancer, severe cardiac, cerebral, liver, kidney diseases, etc;
- Difficult for long-term follow-up visit for any reason.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Usual screening group
ECG recordings at baseline plus at 1 and 2 year of follow-up; three ECG recordings in total.
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Intensive screening subgroup
ECG recordings at baseline plus quarterly during follow-up, at months 3, 6, 9 ,12, 15, 18, 21 and 24; 9 ECG recordings in total.
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More intensive screening subgroup
ECG recordings at baseline plus weekly during the first month of follow-up and quarterly afterwards, at weeks 1, 2, 3 and 4 and months 3, 6, 9, 12, 15, 18, 21 and 24; 13 ECG recordings in total.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups
Periodo de tiempo: 2 year
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2 year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group
Periodo de tiempo: 2 year
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2 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jiguang Wang, MD, PhD, Shanghai Jiao Tong University School of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Zhang W, Chen Y, Miao CY, Huang QF, Sheng CS, Shao S, Wang D, Xu SK, Lei L, Zhang D, Chen YL, Hu LX, Xia JH, Ye XF, Cheng YB, Wang Y, Guo QH, Li Y, Lowres N, Freedman B, Wang JG; AF-CATCH Investigators and Coordinators. Quarterly versus annual ECG screening for atrial fibrillation in older Chinese individuals (AF-CATCH): a prospective, randomised controlled trial. Lancet Healthy Longev. 2021 Aug;2(8):e470-e478. doi: 10.1016/S2666-7568(21)00138-0. Epub 2021 Jul 23.
- Zhang W, Chen Y, Hu LX, Xia JH, Ye XF, Cheng YB, Wang Y, Guo QH, Li Y, Lowres N, Freedman B, Wang JG; AF-CATCH Investigators and Coordinators. Changes in the CHA2DS2-VASC score as a predictor of incident atrial fibrillation in older Chinese individuals: the AF-CATCH study. Eur Heart J Open. 2022 Jul 25;2(4):oeac046. doi: 10.1093/ehjopen/oeac046. eCollection 2022 Jul.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de abril de 2017
Finalización primaria (Actual)
23 de octubre de 2020
Finalización del estudio (Actual)
23 de octubre de 2020
Fechas de registro del estudio
Enviado por primera vez
9 de diciembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
9 de diciembre de 2016
Publicado por primera vez (Estimar)
13 de diciembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
2 de noviembre de 2020
Última verificación
1 de noviembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AF-CATCH
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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