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

NCT02990741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4348

Last updated 2020-11-04

No results posted yet for this study

Summary

1. Study name:A randomized clinical trial on atrial fibrillation screening by using an automated electrocardiogram system in an elderly Chinese population
2. 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.
3. 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.
4. Study design: The present study is designed as a randomized controlled trial of parallel group (two).
5. Study population: Men and women aged at least 65 years (n=7000) meet the inclusion/exclusion criteria.
6. 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.
7. 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.
8. Sample size estimation: The number of required subject for the whole trial is 7000.
9. Timeline: Start of subjects enrollment : December 2016; End of subjects enrollment : June 2017; End of study : October 2020
10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Conditions

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jiguang Wang, MD, PhD · Shanghai Jiao Tong University School of Medicine

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2020-10-23
Completion
2020-10-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02990741 on ClinicalTrials.gov