Atrial FibrillationAF-CATCHNCT02990741
A Clinical Trial Screening for Atrial Fibrillation (AF-CATCH)
An observational study of Atrial Fibrillation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 4,348 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2017to 23 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, automated ECG system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups
Measured: 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
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
17 Apr 201723 Oct 2020
- First posted13 Dec 2016 (estimated)
- Study start17 Apr 2017
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiguang Wang, MD, PhD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990741
- Sponsor's protocol ID
- AF-CATCH
- Acronym
- AF-CATCH
- Status last verified
- Nov 2020
- First submitted
- 9 Dec 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 36097996Zhang 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.
PubMed 35983405
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on Atrial Fibrillation Screening by Using an Automated Electrocardiogram System in an Elderly Chinese Population
- ClinicalTrials.gov ID
- NCT02990741
- Acronym / sponsor ID
- AF-CATCH / AF-CATCH
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, automated ECG system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,348 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups
Time frame: 2 year
1 secondary outcome
Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 36097996Zhang 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.
- Derived from this study: PubMed 35983405Zhang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiguang Wang, MD, PhD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02990741, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.