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A Clinical Trial Screening for Atrial Fibrillation (AF-CATCH) (AF-CATCH)

2020年11月2日更新者：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.

研究概览

地位

完全的

条件

心房颤动

详细说明

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.

研究类型

观察性的

注册 (实际的)

4348

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

中国
- - Shanghai、中国、200025
    - Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Usual screening group ECG recordings at baseline plus at 1 and 2 year of follow-up; three ECG recordings in total.
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.
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.

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups 大体时间：2 year	2 year

次要结果测量

结果测量	大体时间
Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group 大体时间：2 year	2 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Jiao Tong University School of Medicine

调查人员

首席研究员：Jiguang Wang, MD, PhD、Shanghai Jiao Tong University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年4月17日

初级完成 (实际的)

2020年10月23日

研究完成 (实际的)

2020年10月23日

研究注册日期

首次提交

2016年12月9日

首先提交符合 QC 标准的

2016年12月9日

首次发布 (估计)

2016年12月13日

研究记录更新

最后更新发布 (实际的)

2020年11月4日

上次提交的符合 QC 标准的更新

2020年11月2日

最后验证

2020年11月1日