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

NCT02990741 | Completed DMC

• 1 other identifier: AF-CATCH
• Study Type: observational
• Target: 4,348
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; automated ECG system

Outcome Measures

Primary Outcomes (1)

• Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups

  2 year

Secondary Outcomes (1)

• Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group

  2 year

Study Arms (3)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

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 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

Related Publications (2)

• 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.

  PMID: 36097996 DERIVED

• 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.

  PMID: 35983405 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiguang Wang, MD, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: April 17, 2017
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

CN (1)