A Clinical Trial Screening for Atrial Fibrillation (AF-CATCH) (AF-CATCH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02990741|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : July 7, 2020
- 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 year of follow-up; two ECG recordings in total. 2)Intensive screening subgroup: ECG recordings at baseline plus quarterly during follow-up, at months 3, 6, 9 and 12; 5 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 and 12; 9 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 : June 2018
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||4348 participants|
|Official Title:||A Randomized Clinical Trial on Atrial Fibrillation Screening by Using an Automated Electrocardiogram System in an Elderly Chinese Population|
|Actual Study Start Date :||April 17, 2017|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Usual screening group
ECG recordings at baseline plus at 1 year of follow-up; two ECG recordings in total.
Intensive screening subgroup
ECG recordings at baseline plus quarterly during follow-up, at months 3, 6, 9 and 12; 5 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 and 12; 9 ECG recordings in total.
- Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups [ Time Frame: 1 year ]
- Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990741
|Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine|
|Shanghai, China, 200025|
|Principal Investigator:||Jiguang Wang, MD, PhD||Shanghai Jiao Tong University School of Medicine|