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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
Sponsor:
Information provided by (Responsible Party):
Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine

Brief 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 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.
  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 : June 2018
  10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Condition or disease
Atrial Fibrillation

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Study Type : Observational
Actual Enrollment : 4348 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group [ Time Frame: 1 year ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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 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.
  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.

Information from the National Library of Medicine

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


Locations
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China
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Jiguang Wang, MD, PhD Shanghai Jiao Tong University School of Medicine
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Responsible Party: Ji-Guang Wang, Director of the Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02990741    
Other Study ID Numbers: AF-CATCH
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine:
atrial fibrillation
automated ECG system
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes