<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02990741</url>
  </required_header>
  <id_info>
    <org_study_id>AF-CATCH</org_study_id>
    <nct_id>NCT02990741</nct_id>
  </id_info>
  <brief_title>A Clinical Trial Screening for Atrial Fibrillation (AF-CATCH)</brief_title>
  <acronym>AF-CATCH</acronym>
  <official_title>A Randomized Clinical Trial on Atrial Fibrillation Screening by Using an Automated Electrocardiogram System in an Elderly Chinese Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Study name:A randomized clinical trial on atrial fibrillation screening by using an&#xD;
           automated electrocardiogram system in an elderly Chinese population&#xD;
&#xD;
        2. Rationale: Failure in the diagnosis and management of atrial fibrillation leads to high&#xD;
           incidence of stroke and high mortality and disability. It is therefore imperative to&#xD;
           diagnose and manage atrial fibrillation in a timely and effective fashion to prevent the&#xD;
           complications of atrial fibrillation.&#xD;
&#xD;
        3. Objective:The primary objective is to investigate whether more frequent ECG recordings&#xD;
           and analyses with this automated ECG system (4 times/year) would significantly improve&#xD;
           the detection of atrial fibrillation compared to a single annual ECG screen.The&#xD;
           secondary objective is to explore whether even more frequent ECG recordings and analyses&#xD;
           (8 times/year) would further improve the detection of atrial fibrillation.&#xD;
&#xD;
        4. Study design: The present study is designed as a randomized controlled trial of parallel&#xD;
           group (two).&#xD;
&#xD;
        5. Study population: Men and women aged at least 65 years (n=7000) meet the&#xD;
           inclusion/exclusion criteria.&#xD;
&#xD;
        6. Randomization and treatment: Eligible subjects will be randomized in a 1:1 ratio into&#xD;
           the usual and intensive screening groups with 3500 patients in each group, and within&#xD;
           the intensive screening group in a 3:1 ratio into the intensive and more intensive&#xD;
           subgroups with 2625 and 875 patients, respectively.&#xD;
&#xD;
        7. Follow up: 1)Usual screening group: ECG recordings at baseline plus at 1 and 2 year of&#xD;
           follow-up; three ECG recordings in total. 2)Intensive screening subgroup: ECG recordings&#xD;
           at baseline plus quarterly during follow-up, at months 3, 6, 9, 12, 15, 18, 21 and 24; 9&#xD;
           ECG recordings in total. 3)More intensive screening subgroup: ECG recordings at baseline&#xD;
           plus weekly during the first month of follow-up and quarterly afterwards, at weeks 1, 2,&#xD;
           3 and 4 and months 3, 6, 9, 12, 15, 18, 21 and 24; 13 ECG recordings in total.&#xD;
&#xD;
        8. Sample size estimation: The number of required subject for the whole trial is 7000.&#xD;
&#xD;
        9. Timeline: Start of subjects enrollment : December 2016; End of subjects enrollment :&#xD;
           June 2017; End of study : October 2020&#xD;
&#xD;
       10. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin&#xD;
           Hospital, Shanghai, China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Study name:A randomized clinical trial on atrial fibrillation screening by using an&#xD;
           automated electrocardiogram system in an elderly Chinese population&#xD;
&#xD;
        2. Rationale: The incidence of atrial fibrillation rises continuously.The main detrimental&#xD;
           effect of atrial fibrillation is its complication of stroke.Failure in the diagnosis and&#xD;
           management of atrial fibrillation before the incidence of stroke leads to high mortality&#xD;
           and disability. It is therefore imperative to diagnose and manage atrial fibrillation in&#xD;
           a timely and effective fashion and prevent the complications of atrial fibrillation, by&#xD;
           screening followed by the use of proven therapy, such as warfarin. An automated handheld&#xD;
           ECG system based on a smartphone has recently become available for the screening of&#xD;
           atrial fibrillation in high risk people.However, how this system can be most effectively&#xD;
           used for the widespread screening of atrial fibrillation remains a question that&#xD;
           requires investigation. Moreover, while repeated recordings will have a higher yield of&#xD;
           atrial fibrillation diagnosis [11], it is not certain what constitutes an optimum number&#xD;
           of ECG recordings balancing cost and effectiveness. The present study was therefore&#xD;
           designed as a randomized controlled trial to investigate whether more frequent ECG&#xD;
           recordings and analyses with this automated ECG system would significantly improve the&#xD;
           detection of atrial fibrillation compared to a single annual ECG screen in elderly&#xD;
           Chinese population in the community health centre.&#xD;
&#xD;
        3. Objective:The primary objective is to investigate whether more frequent ECG recordings&#xD;
           and analyses with this automated ECG system (4 times/year) would significantly improve&#xD;
           the detection of atrial fibrillation compared to a single annual ECG screen.The&#xD;
           secondary objective is to explore whether even more frequent ECG recordings and analyses&#xD;
           (8 times/year) would further improve the detection of atrial fibrillation.&#xD;
&#xD;
        4. Study design: The present study is designed as a randomized controlled trial of parallel&#xD;
           group (two)&#xD;
&#xD;
        5. Study population: Men and women aged at least 65 years (n=7000) will be recruited from 5&#xD;
           community health centers in the city of Shanghai. Eligible patients should meet the&#xD;
           following inclusion and exclusion criteria.Inclusion Criteria:1) Age≥65 years; 2)&#xD;
           Absence of atrial fibrillation at baseline; 3) Willing and capable to visit the&#xD;
           outpatient clinic on his/her own for long-term follow-up. Exclusion Criteria:1) Known&#xD;
           persistent or paroxysmal atrial fibrillation : Sinus rhythm after pharmacological or&#xD;
           electric cardioversion, or radiofrequency ablation;Use of anticoagulant therapy and&#xD;
           atrial fibrillation;Use of medication for heart rate control;Untreated atrial&#xD;
           fibrillation.2) Serious life-threatening diseases, such as, cancer, severe cardiac,&#xD;
           cerebral, liver, kidney diseases, etc;3) Difficult for long-term follow-up visit for any&#xD;
           reason&#xD;
&#xD;
        6. Randomization and treatment: Eligible subjects will be randomized in a 1:1 ratio into&#xD;
           the usual and intensive screening groups with 3500 patients in each group, and within&#xD;
           the intensive screening group in a 3:1 ratio into the intensive and more intensive&#xD;
           subgroups with 2625 and 875 patients, respectively. 1)Usual screening group: ECG&#xD;
           recordings at baseline plus at 1 and 2 year of follow-up; three ECG recordings in total.&#xD;
           2)Intensive screening subgroup: ECG recordings at baseline plus quarterly during&#xD;
           follow-up, at months 3, 6, 9,12, 15, 18, 21 and 24; 9 ECG recordings in total. 3)More&#xD;
           intensive screening subgroup: ECG recordings at baseline plus weekly during the first&#xD;
           month of follow-up and quarterly afterwards, at weeks 1, 2, 3 and 4 and months 3, 6, 9,&#xD;
           12, 15, 18, 21 and 24; 13 ECG recordings in total. The automated electrocardiogram&#xD;
           analysis system AliveCor® Heart Monitor will be used to perform ECG recordings and&#xD;
           analysis for the immediate diagnosis of atrial fibrillation. At one and two year of&#xD;
           follow-up, a follow-up questionnaire will be administered and physical examinations will&#xD;
           be performed. All detected cases of atrial fibrillation will be further evaluated with a&#xD;
           regular 12-lead ECG, and then referred to a specialists' centre for treatment.&#xD;
&#xD;
        7. Follow up: In the usual screening group, patients will be followed-up in the community&#xD;
           health centre at baseline and at 12 and 24 months of follow-up. In the intensive&#xD;
           screening group, patients will be followed-up at baseline and at 3, 6, 9, 12, 15, 18, 21&#xD;
           and 24 months of follow-up. In the more intensive screening subgroup, patients will be&#xD;
           followed-up weekly in the first month of follow-up and at 3, 6, 9, 12, 15, 18, 21 and 24&#xD;
           months of follow-up.&#xD;
&#xD;
        8. Sample size estimation: The detection rate of atrial fibrillation by a single 12-lead&#xD;
           ECG was 2.5% in elderly people living in Shanghai Of the 2.5%, only 0.5% were aware of&#xD;
           atrial fibrillation. The detection rate of atrial fibrillation by an ECG recording at&#xD;
           baseline and another in 12 months could be estimated to be 2.0% in elderly people&#xD;
           without awareness of atrial fibrillation. The primary hypothesis is that the detection&#xD;
           rate could be improved by 50% with more frequent ECG recordings. If =0.05, power=80% and&#xD;
           one-sided test are assumed, and a 1:1 ratio would be used to assign patients to usual&#xD;
           and intensive ECG screening, the study will require a sample size of 3013 subjects per&#xD;
           group. In consideration of a 15% of super-addition, approximately 3500 eligible subjects&#xD;
           per group should be enrolled. The number of required subjects for the whole trial is&#xD;
           7000.&#xD;
&#xD;
        9. Timeline : Enrollment rate : 1000 patients /month ; Planned publication /presentation :&#xD;
           October 2020; Start of subjects enrollment : December 2016; End of subjects enrollment :&#xD;
           June 2017; End of study : October 2020&#xD;
&#xD;
       10. Organization: The study will be conducted in a single research center (Ruijin Hospital)&#xD;
           with 5 community health centers. Patients will be recruited and followed up by the&#xD;
           community health physicians in 5 community health centers, under the supervision of&#xD;
           cardiologists from Ruijin Hospital. ECG will be recorded in each of the community health&#xD;
           centers. Atrial fibrillation will be initially diagnosed by the software build in the&#xD;
           smart phone. ECG will also be transmitted to a cloud platform for storage and further&#xD;
           analysis. If atrial fibrillation is detected, a 12-lead ECG will be immediately&#xD;
           performed for the verification and confirmation of the diagnosis of atrial fibrillation.&#xD;
           The identified patients with atrial fibrillation will be referred to the outpatient&#xD;
           clinic of Ruijin Hospital for management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups</measure>
    <time_frame>2 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">4348</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Usual screening group</arm_group_label>
    <description>ECG recordings at baseline plus at 1 and 2 year of follow-up; three ECG recordings in total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive screening subgroup</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>More intensive screening subgroup</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women aged at least 65 years (n=7000) will be recruited from 5 community health&#xD;
        centers in the city of Shanghai and randomized into a group of more frequent (4 or 8) ECG&#xD;
        recordings and analyses (n=3500) and a group of a single ECG recording and analysis during&#xD;
        12 months of follow-up (n=3500). The intensive screening group will be further randomly&#xD;
        divided into intensive (n=2625) and more intensive subgroups (n=875). Eligible patients&#xD;
        should meet the following inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 65 years;&#xD;
&#xD;
          2. Absence of atrial fibrillation at baseline;&#xD;
&#xD;
          3. Willing and capable to visit the outpatient clinic on his/her own for long-term&#xD;
             follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known persistent or paroxysmal atrial fibrillation 1)Sinus rhythm after&#xD;
             pharmacological or electric cardioversion, or radiofrequency ablation; 2)Use of&#xD;
             anticoagulant therapy and atrial fibrillation; 3)Use of medication for heart rate&#xD;
             control; 4)Untreated atrial fibrillation.&#xD;
&#xD;
          2. Serious life-threatening diseases, such as, cancer, severe cardiac, cerebral, liver,&#xD;
             kidney diseases, etc;&#xD;
&#xD;
          3. Difficult for long-term follow-up visit for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiguang Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ji-Guang Wang</investigator_full_name>
    <investigator_title>Director of the Shanghai Institute of Hypertension</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>automated ECG system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02990741
org study id: AF-CATCH
nct id: NCT02990741
lead sponsor: 
has dmc: Yes
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.
1. Study name:A randomized clinical trial on atrial fibrillation screening by using an
           automated electrocardiogram system in an elderly Chinese population

        2. 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.

        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) 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

        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. 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.

        7. 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.

        8. 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.

        9. 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

       10. 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.
observational model: Cohort
time perspective: Prospective
measure: Difference in the detection rate of atrial fibrillation between the usual and the intensive screening groups
time frame: 2 year
measure: Difference in the detection rate of atrial fibrillation between the intensive and more intensive screening subgroups within the intensive group
time frame: 2 year
arm group label: Usual screening group
description: ECG recordings at baseline plus at 1 and 2 year of follow-up; three ECG recordings in total.
arm group label: Intensive screening subgroup
description: 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.
arm group label: More intensive screening subgroup
description: 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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jiguang Wang, MD, PhD
role: Principal Investigator
affiliation: Shanghai Jiao Tong University School of Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Ji-Guang Wang
investigator title: Director of the Shanghai Institute of Hypertension
mesh term: Atrial Fibrillation
sharing ipd: Undecided