<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/NCT04437914</url>
  </required_header>
  <id_info>
    <org_study_id>FUPiaui</org_study_id>
    <nct_id>NCT04437914</nct_id>
  </id_info>
  <brief_title>Accuracy of Cardiac Arrhythmias and Conduction Disorders Diagnosis Using a Smartwatch</brief_title>
  <official_title>Accuracy of Cardiac Arrhythmias and Conduction Disorders Diagnosis Using Smartwatch in Comparison to Conventional Electrocardiogram in Patients With Cardiovascular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Piaui</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Piaui</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implantable devices increase the detection of silent atrial fibrillation in high-risk&#xD;
      populations, being a useful tool in the early diagnosis of these patients, allowing&#xD;
      monitoring for a longer time. Currently, these devices can be used for monitoring and&#xD;
      possible early diagnosis of abnormalities in order to prevent health complications and bring&#xD;
      about better outcomes, as well as monitor the user's progress and thus prevent more serious&#xD;
      developments. Objective: to analyze, in patients with cardiovascular disease, the&#xD;
      electrocardiographic aspects detected from the device in comparison to the conventional&#xD;
      electrocardiogram, identifying aspects of similarity between the tracings obtained and&#xD;
      automatic diagnostic accuracy by the device and by the visual assessment of the tracing.&#xD;
      Method: a cross-sectional observational study of diagnostic accuracy will be carried out at&#xD;
      the University Hospital of the Federal University of Piaui. The following parameters were&#xD;
      considered: significance level of 95%, test power of 80%, value of the disease diagnosis rate&#xD;
      of 84%, area under the receiver operating characteristic curve of 94% and an equal proportion&#xD;
      of the number of positive and negative cases. The minimum sample size consisted of 100&#xD;
      patients, and an additional 10% will be added to compensate for possible losses. A total of&#xD;
      110 patients will be invited to participate in the study. Patients aged ≥ 18 years will be&#xD;
      included, with the presence of one or more diagnoses below: systemic arterial hypertension,&#xD;
      heart failure, valvular disease, coronary atherosclerotic disease, myocardial infarction,&#xD;
      endocarditis, myocarditis, diabetes, cardiac arrhythmias and patients with cardiac pace or&#xD;
      implantable automatic defibrillator. The variables analyzed will be: clinical-demographic&#xD;
      data of the patients, including age, sex, race, socioeconomic profile; comorbidities and&#xD;
      electrocardiographic findings as measured by the clock and conventional ECG. The data will be&#xD;
      analyzed comparatively between the groups: 1 = EKG on the clock; 2 = 12-lead conventional EKG&#xD;
      and DI (single lead). The primary outcome will be the positive diagnostic correlation of the&#xD;
      data obtained in group 1 in relation to group 2. Secondary outcomes: successful measurement&#xD;
      of the electrocardiographic record by the clock; diagnostic accuracy of atrial fibrillation&#xD;
      and other heart rhythm disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective of this study is to analyze, in patients with cardiovascular disease, the&#xD;
      electrocardiographic aspects detected from the smartwatch device in comparison to the&#xD;
      conventional electrocardiogram, identifying aspects of similarity between the tracings&#xD;
      obtained and automatic diagnostic accuracy by the device and by visual assessment. of the&#xD;
      layout. The secondary objectives will be to evaluate in the same population: aspects of&#xD;
      practicality for the use of smart watches in clinical practice in cardiology; the success&#xD;
      rate in obtaining the electrocardiographic tracing with adequate quality by the smart watch&#xD;
      and describe the types of failure and assess the clinical characteristics related to the&#xD;
      failure in obtaining the electrocardiographic tracing by the smart watch. Method: An&#xD;
      observational, transversal, study of diagnostic accuracy will be carried out at the&#xD;
      University Hospital of the Federal University of Piaui.&#xD;
&#xD;
      The sample size was calculated using MedCalc Statistical Software version 19.2.3 (MedCalc&#xD;
      Software Ltd, Ostend, Belgium). For the sample calculation, the following parameters were&#xD;
      considered: significance level of 95%, test power of 80%, value of the disease diagnosis rate&#xD;
      of 84%, area under the receiver operating characteristic curve of 94% and equal proportion of&#xD;
      number of positive and negative cases. The minimum sample size consisted of 100 patients, and&#xD;
      an additional 10% will be added to compensate for possible losses. A total of 110 patients&#xD;
      will be invited to participate in the study. Inclusion criteria: • Age ≥ 18 years;&#xD;
&#xD;
      • Patients followed up in the cardiology sector, hospitalized or outpatient, with the&#xD;
      presence of one or more of the following diagnoses: systemic arterial hypertension, heart&#xD;
      failure, valve disease, coronary atherosclerotic disease, myocardial infarction,&#xD;
      endocarditis, myocarditis, diabetes, cardiac arrhythmias and patients with cardiac pacemakers&#xD;
      or implantable automatic defibrillators. Exclusion criteria: • Patients who have&#xD;
      electrocardiographic tracings, whether obtained from the watch or the conventional method, of&#xD;
      poor quality that make it impossible or that makes the diagnosis difficult due to the&#xD;
      technical aspect of the performance. • Withdrawal of the consent form at the request of the&#xD;
      patient or guardian. Primary outcome: • Positive diagnostic correlation of the data obtained&#xD;
      in group 1 (clock) in relation to group 2 (conventional ECG 12 leads and DI - single lead).&#xD;
      Secondary outcome: • Successful verification of the electrocardiographic record by the watch;&#xD;
      • Diagnostic accuracy of atrial fibrillation; • Diagnostic accuracy of heart rhythm&#xD;
      disorders, excluding atrial fibrillation. Ethical aspects: All patients will be informed&#xD;
      about the principles and objectives of the protocol before inclusion in the study and will be&#xD;
      given explanations of potential advantages or disadvantages. All procedures involved in this&#xD;
      study will be in accordance with the Helsinki Declaration of 1975, updated in 2013. The study&#xD;
      will follow the principles of good clinical practice and the terms of Resolution No. 466/12&#xD;
      of December 12, 2012 of the National Health Council Ministry of Health. All patients or legal&#xD;
      guardians will sign the informed consent form in writing before selection. Patients will be&#xD;
      guaranteed that early withdrawal from the study will always be possible, without any&#xD;
      consequence or impairment in their subsequent medical care. Data will be collected only after&#xD;
      approval by the ethics and research committee. Those who do not sign the Informed Consent&#xD;
      will not be included. Data collect The variables analyzed will be: clinical-demographic data&#xD;
      of the patients, including age, sex, race, socioeconomic profile; comorbidities and&#xD;
      electrocardiographic findings as measured by the clock and conventional ECG. The data will be&#xD;
      analyzed comparatively between the groups: 1 = ECG on the clock; 2 = 12-lead conventional ECG&#xD;
      and DI (single lead).&#xD;
&#xD;
      Electrocardiographic recording devices The smart watch used will be the Apple Watch series 4,&#xD;
      from Apple Inc. (Specifications: Sensor I, 511 Hz, mobile operating system 13.1.3, operating&#xD;
      system 6.0.1, Watch 4.2). For the recording of the conventional electrocardiogram, a mobile&#xD;
      device will be used that allows the recording of 12 simultaneous leads and the rhythm tracing&#xD;
      of the DI lead.&#xD;
&#xD;
      Criteria for electrocardiographic diagnosis The criteria for electrocardiographic diagnosis&#xD;
      of morphological aspects, intervals and conclusive report will be based on the guideline of&#xD;
      the Brazilian Society of Cardiology on the analysis and issuance of electrocardiographic&#xD;
      reports.&#xD;
&#xD;
      For the analysis of similarity between the traces obtained by the clock and the conventional&#xD;
      ECG, the parameters of regularity of the RR cycle beat by beat, heart rate in beats per&#xD;
      minute, amplitude and duration of the p wave, QRS and T wave will be evaluated, in addition&#xD;
      to the PR and QT corrected intervals. The unit in milliseconds will be used for the duration&#xD;
      and millimeters for the amplitude. To obtain the automatic electrocardiographic diagnosis of&#xD;
      the clock, two ECG tracings of 30 seconds will be obtained, in a calm environment, with the&#xD;
      patient at rest, in the horizontal supine position.&#xD;
&#xD;
      The device will be attached to the wrist on the left side with the use of the fingers of the&#xD;
      right hand on the sensor button of the watch to complete the electrocardiographic DI&#xD;
      derivation following the Einthoven triangle derivation criteria. The automatic diagnosis&#xD;
      obtained must be the same in both plots to be validated. A third trace will be performed if&#xD;
      the automatic diagnosis of the second trace is different from the first analysis. If there is&#xD;
      a new divergence in the automatic diagnosis of the clock's third ECG trace in relation to the&#xD;
      two previously obtained traces, the diagnosis will be considered inconclusive. The specific&#xD;
      results of the automatic diagnosis obtained by the watch will be: low beats with FC≤40 beats&#xD;
      per minute (bpm); high beats with HR≥120bpm; sinus rhythm when interpreted as normal by the&#xD;
      clock, atrial fibrillation, inconclusive and does not allow analysis due to poor technical&#xD;
      quality and did not allow tracing. The conventional ECG tracing will be obtained in the 12&#xD;
      leads of the frontal plane (DI, DII, DIII, aVR, AVL, AVF) and the horizontal plane (V1 to V6)&#xD;
      and a 30-second rhythm trace in the DI lead. The diagnostic results of conventional ECG&#xD;
      tracings will be: normal or abnormal; sinus rhythm, AF, atrial flutter or other non-sinus&#xD;
      rhythm; intraventricular conduction disorder: left bundle branch block (BRE), right bundle&#xD;
      branch block (BRD), right posteroinferior lower block (BDPI or left anterior superior (BDAS),&#xD;
      isolated or associated; normal electrical axis, shifted to the right or shifted to the right)&#xD;
      left, inconclusive and does not allow analysis due to poor technical quality. The&#xD;
      electrocardiographic tracings will be analyzed blindly by two independent cardiologists with&#xD;
      a cardiology degree from Brazilian Medical Association and Brazilian Society of Cardiology&#xD;
      and not participating in the research data collection stage. Statistical analysis: The two&#xD;
      independent cardiologists will be evaluated for calibration using the Kappa method of&#xD;
      agreement. If there is disagreement regarding the diagnosis of the two cardiologists, the&#xD;
      divergent path in question will be evaluated by the main researcher of the research. The&#xD;
      normal distribution of variables will be verified using the Shapiro-Wilk test, where&#xD;
      continuous variables with normal distribution will be expressed as means and standard&#xD;
      deviation (SD) using the chi-square test for comparison between groups. Variables with&#xD;
      non-Gaussian distribution will be expressed as medians and interquartile ranges using&#xD;
      Mann-Whitney tests for comparison between groups. For statistical significance, p &lt;0.05 and&#xD;
      95% confidence interval will be considered. The analyzes will be performed using the&#xD;
      Statistical Package for the Social Sciences (SPSS®, version 22.0 for Windows®).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 7, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Actual">August 30, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Positive diagnostic correlation</measure>
    <time_frame>30 days</time_frame>
    <description>Positive diagnostic correlation of the data obtained in group 1 (clock) in relation to group 2 (conventional ECG 12 leads and DI - single lead).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy 1</measure>
    <time_frame>30 days</time_frame>
    <description>Diagnostic accuracy of atrial fibrillation;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy 2</measure>
    <time_frame>30 days</time_frame>
    <description>Diagnostic accuracy of heart rhythm disorders, excluding atrial fibrillation.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Cardiac Arrhythmia</condition>
  <condition>Conduction Disturbance</condition>
  <arm_group>
    <arm_group_label>Group 1 - Smartwatch - single lead (D1)</arm_group_label>
    <description>To obtain the automatic electrocardiographic diagnosis of the clock, two ECG tracings of 30 seconds will be obtained, in a calm environment, with the patient at rest, in the horizontal supine position. The device will be attached to the wrist on the left side with the use of the fingers of the right hand on the sensor button of the watch to complete the electrocardiographic DI derivation following the Einthoven triangle derivation criteria. The automatic diagnosis obtained must be the same in both plots to be validated. The specific results of the automatic diagnosis obtained by the watch will be: low beats with FC≤40 beats per minute (bpm); high beats with HR≥120bpm; sinus rhythm when interpreted as normal by the clock, atrial fibrillation, inconclusive and does not allow analysis due to poor technical quality and did not allow tracing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - conventional ECG</arm_group_label>
    <description>The conventional ECG tracing will be obtained in the 12 leads of the frontal plane (DI, DII, DIII, aVR, AVL, AVF) and the horizontal plane (V1 to V6) and a 30-second rhythm trace in the DI lead. The diagnostic results of conventional ECG tracings will be: normal or abnormal; sinus rhythm, AF, atrial flutter or other non-sinus rhythm; intraventricular conduction disorder: left bundle branch block (BRE), right bundle branch block (BRD), right posteroinferior lower block (BDPI or left anterior superior (BDAS), isolated or associated; normal electrical axis, shifted to the right or shifted to the right) left, inconclusive and does not allow analysis due to poor technical quality.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Electrocardiogram diagnosis</intervention_name>
    <description>Electrocardiographic diagnosis will be made in a double-blind manner by two specialists in cardiology and cardiac arrhythmias and the results will be compared between the groups studied.</description>
    <arm_group_label>Group 1 - Smartwatch - single lead (D1)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients followed up in the cardiology sector, hospitalized or outpatient, with the&#xD;
        presence of the inclusion criteria and without exclusion criteria.&#xD;
&#xD;
        The sample size was calculated using MedCalc Statistical Software version 19.2.3 (MedCalc&#xD;
        Software Ltd, Ostend, Belgium). For the sample calculation, the following parameters were&#xD;
        considered: significance level of 95%, test power of 80%, value of the disease diagnosis&#xD;
        rate of 84%, area under the ROC curve of 94% and equal proportion of number of positive and&#xD;
        negative cases. The minimum sample size consisted of 100 patients, and an additional 10%&#xD;
        will be added to compensate for possible losses. A total of 110 patients will be invited to&#xD;
        participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  Presence of one or more of the following diagnoses: systemic arterial hypertension,&#xD;
             heart failure, valve disease, coronary atherosclerotic disease, myocardial infarction,&#xD;
             endocarditis, myocarditis, diabetes, cardiac arrhythmias and patients with cardiac&#xD;
             pacemakers or implantable automatic defibrillators.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have electrocardiographic tracings, whether obtained from the watch or&#xD;
             the conventional method, of poor quality that make it impossible or that makes the&#xD;
             diagnosis difficult due to the technical aspect of the performance.&#xD;
&#xD;
          -  Withdrawal of the consent form at the request of the patient or guardian.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Eduardo B de Lima, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Piaui</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carlos Eduardo B. Lima, MD, PhD</last_name>
    <phone>+5586981805000</phone>
    <email>carlos.lima@ufpi.edu.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carlos Eduardo B. Lima, MD, PhD</last_name>
    <phone>+55863085-3048</phone>
    <email>cardiolima.medicalcenter@hotmail.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Carlos Eduardo B. de Lima</name>
      <address>
        <city>Teresina</city>
        <state>Piauí</state>
        <zip>64048-350</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlos Eduardo B de Lima, MD, PhD</last_name>
      <phone>86981805000</phone>
      <email>carlos.lima@ufpi.edu.br</email>
    </contact>
    <contact_backup>
      <last_name>Amanda Sousa</last_name>
      <phone>86994615203</phone>
      <email>admin@cardiolima.com.br</email>
    </contact_backup>
    <investigator>
      <last_name>Guilherme N. Miranda, Medicine Student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Italiano A. Filho, Medicine Student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Lima C, Martinelli M, Peixoto GL, Siqueira SF, Wajngarten M, Silva RT, Costa R, Filho R, Ramires JA. Silent Atrial Fibrillation in Elderly Pacemaker Users: A Randomized Trial Using Home Monitoring. Ann Noninvasive Electrocardiol. 2016 May;21(3):246-55. doi: 10.1111/anec.12294. Epub 2015 Sep 28.</citation>
    <PMID>26413928</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Piaui</investigator_affiliation>
    <investigator_full_name>Carlos Eduardo Batista de Lima, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine (Cardiology)</investigator_title>
  </responsible_party>
  <keyword>Artificial Intelligence</keyword>
  <keyword>Cardiac Arrhythmia</keyword>
  <keyword>Smartwatch</keyword>
  <keyword>Cardiac Conduction System Disturbance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Cardiac Conduction System Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>I have no plan to share individual patient data with other researchers.</ipd_description>
  </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/NCT04437914
org study id: FUPiaui
nct id: NCT04437914
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Implantable devices increase the detection of silent atrial fibrillation in high-risk
      populations, being a useful tool in the early diagnosis of these patients, allowing
      monitoring for a longer time. Currently, these devices can be used for monitoring and
      possible early diagnosis of abnormalities in order to prevent health complications and bring
      about better outcomes, as well as monitor the user's progress and thus prevent more serious
      developments. Objective: to analyze, in patients with cardiovascular disease, the
      electrocardiographic aspects detected from the device in comparison to the conventional
      electrocardiogram, identifying aspects of similarity between the tracings obtained and
      automatic diagnostic accuracy by the device and by the visual assessment of the tracing.
      Method: a cross-sectional observational study of diagnostic accuracy will be carried out at
      the University Hospital of the Federal University of Piaui. The following parameters were
      considered: significance level of 95%, test power of 80%, value of the disease diagnosis rate
      of 84%, area under the receiver operating characteristic curve of 94% and an equal proportion
      of the number of positive and negative cases. The minimum sample size consisted of 100
      patients, and an additional 10% will be added to compensate for possible losses. A total of
      110 patients will be invited to participate in the study. Patients aged ≥ 18 years will be
      included, with the presence of one or more diagnoses below: systemic arterial hypertension,
      heart failure, valvular disease, coronary atherosclerotic disease, myocardial infarction,
      endocarditis, myocarditis, diabetes, cardiac arrhythmias and patients with cardiac pace or
      implantable automatic defibrillator. The variables analyzed will be: clinical-demographic
      data of the patients, including age, sex, race, socioeconomic profile; comorbidities and
      electrocardiographic findings as measured by the clock and conventional ECG. The data will be
      analyzed comparatively between the groups: 1 = EKG on the clock; 2 = 12-lead conventional EKG
      and DI (single lead). The primary outcome will be the positive diagnostic correlation of the
      data obtained in group 1 in relation to group 2. Secondary outcomes: successful measurement
      of the electrocardiographic record by the clock; diagnostic accuracy of atrial fibrillation
      and other heart rhythm disorders.
The main objective of this study is to analyze, in patients with cardiovascular disease, the
      electrocardiographic aspects detected from the smartwatch device in comparison to the
      conventional electrocardiogram, identifying aspects of similarity between the tracings
      obtained and automatic diagnostic accuracy by the device and by visual assessment. of the
      layout. The secondary objectives will be to evaluate in the same population: aspects of
      practicality for the use of smart watches in clinical practice in cardiology; the success
      rate in obtaining the electrocardiographic tracing with adequate quality by the smart watch
      and describe the types of failure and assess the clinical characteristics related to the
      failure in obtaining the electrocardiographic tracing by the smart watch. Method: An
      observational, transversal, study of diagnostic accuracy will be carried out at the
      University Hospital of the Federal University of Piaui.

      The sample size was calculated using MedCalc Statistical Software version 19.2.3 (MedCalc
      Software Ltd, Ostend, Belgium). For the sample calculation, the following parameters were
      considered: significance level of 95%, test power of 80%, value of the disease diagnosis rate
      of 84%, area under the receiver operating characteristic curve of 94% and equal proportion of
      number of positive and negative cases. The minimum sample size consisted of 100 patients, and
      an additional 10% will be added to compensate for possible losses. A total of 110 patients
      will be invited to participate in the study. Inclusion criteria: • Age ≥ 18 years;

      • Patients followed up in the cardiology sector, hospitalized or outpatient, with the
      presence of one or more of the following diagnoses: systemic arterial hypertension, heart
      failure, valve disease, coronary atherosclerotic disease, myocardial infarction,
      endocarditis, myocarditis, diabetes, cardiac arrhythmias and patients with cardiac pacemakers
      or implantable automatic defibrillators. Exclusion criteria: • Patients who have
      electrocardiographic tracings, whether obtained from the watch or the conventional method, of
      poor quality that make it impossible or that makes the diagnosis difficult due to the
      technical aspect of the performance. • Withdrawal of the consent form at the request of the
      patient or guardian. Primary outcome: • Positive diagnostic correlation of the data obtained
      in group 1 (clock) in relation to group 2 (conventional ECG 12 leads and DI - single lead).
      Secondary outcome: • Successful verification of the electrocardiographic record by the watch;
      • Diagnostic accuracy of atrial fibrillation; • Diagnostic accuracy of heart rhythm
      disorders, excluding atrial fibrillation. Ethical aspects: All patients will be informed
      about the principles and objectives of the protocol before inclusion in the study and will be
      given explanations of potential advantages or disadvantages. All procedures involved in this
      study will be in accordance with the Helsinki Declaration of 1975, updated in 2013. The study
      will follow the principles of good clinical practice and the terms of Resolution No. 466/12
      of December 12, 2012 of the National Health Council Ministry of Health. All patients or legal
      guardians will sign the informed consent form in writing before selection. Patients will be
      guaranteed that early withdrawal from the study will always be possible, without any
      consequence or impairment in their subsequent medical care. Data will be collected only after
      approval by the ethics and research committee. Those who do not sign the Informed Consent
      will not be included. Data collect The variables analyzed will be: clinical-demographic data
      of the patients, including age, sex, race, socioeconomic profile; comorbidities and
      electrocardiographic findings as measured by the clock and conventional ECG. The data will be
      analyzed comparatively between the groups: 1 = ECG on the clock; 2 = 12-lead conventional ECG
      and DI (single lead).

      Electrocardiographic recording devices The smart watch used will be the Apple Watch series 4,
      from Apple Inc. (Specifications: Sensor I, 511 Hz, mobile operating system 13.1.3, operating
      system 6.0.1, Watch 4.2). For the recording of the conventional electrocardiogram, a mobile
      device will be used that allows the recording of 12 simultaneous leads and the rhythm tracing
      of the DI lead.

      Criteria for electrocardiographic diagnosis The criteria for electrocardiographic diagnosis
      of morphological aspects, intervals and conclusive report will be based on the guideline of
      the Brazilian Society of Cardiology on the analysis and issuance of electrocardiographic
      reports.

      For the analysis of similarity between the traces obtained by the clock and the conventional
      ECG, the parameters of regularity of the RR cycle beat by beat, heart rate in beats per
      minute, amplitude and duration of the p wave, QRS and T wave will be evaluated, in addition
      to the PR and QT corrected intervals. The unit in milliseconds will be used for the duration
      and millimeters for the amplitude. To obtain the automatic electrocardiographic diagnosis of
      the clock, two ECG tracings of 30 seconds will be obtained, in a calm environment, with the
      patient at rest, in the horizontal supine position.

      The device will be attached to the wrist on the left side with the use of the fingers of the
      right hand on the sensor button of the watch to complete the electrocardiographic DI
      derivation following the Einthoven triangle derivation criteria. The automatic diagnosis
      obtained must be the same in both plots to be validated. A third trace will be performed if
      the automatic diagnosis of the second trace is different from the first analysis. If there is
      a new divergence in the automatic diagnosis of the clock's third ECG trace in relation to the
      two previously obtained traces, the diagnosis will be considered inconclusive. The specific
      results of the automatic diagnosis obtained by the watch will be: low beats with FC≤40 beats
      per minute (bpm); high beats with HR≥120bpm; sinus rhythm when interpreted as normal by the
      clock, atrial fibrillation, inconclusive and does not allow analysis due to poor technical
      quality and did not allow tracing. The conventional ECG tracing will be obtained in the 12
      leads of the frontal plane (DI, DII, DIII, aVR, AVL, AVF) and the horizontal plane (V1 to V6)
      and a 30-second rhythm trace in the DI lead. The diagnostic results of conventional ECG
      tracings will be: normal or abnormal; sinus rhythm, AF, atrial flutter or other non-sinus
      rhythm; intraventricular conduction disorder: left bundle branch block (BRE), right bundle
      branch block (BRD), right posteroinferior lower block (BDPI or left anterior superior (BDAS),
      isolated or associated; normal electrical axis, shifted to the right or shifted to the right)
      left, inconclusive and does not allow analysis due to poor technical quality. The
      electrocardiographic tracings will be analyzed blindly by two independent cardiologists with
      a cardiology degree from Brazilian Medical Association and Brazilian Society of Cardiology
      and not participating in the research data collection stage. Statistical analysis: The two
      independent cardiologists will be evaluated for calibration using the Kappa method of
      agreement. If there is disagreement regarding the diagnosis of the two cardiologists, the
      divergent path in question will be evaluated by the main researcher of the research. The
      normal distribution of variables will be verified using the Shapiro-Wilk test, where
      continuous variables with normal distribution will be expressed as means and standard
      deviation (SD) using the chi-square test for comparison between groups. Variables with
      non-Gaussian distribution will be expressed as medians and interquartile ranges using
      Mann-Whitney tests for comparison between groups. For statistical significance, p <0.05 and
      95% confidence interval will be considered. The analyzes will be performed using the
      Statistical Package for the Social Sciences (SPSS®, version 22.0 for Windows®).
observational model: Cohort
time perspective: Cross-Sectional
measure: Positive diagnostic correlation
time frame: 30 days
description: Positive diagnostic correlation of the data obtained in group 1 (clock) in relation to group 2 (conventional ECG 12 leads and DI - single lead).
measure: Diagnostic accuracy 1
time frame: 30 days
description: Diagnostic accuracy of atrial fibrillation;
measure: Diagnostic accuracy 2
time frame: 30 days
description: Diagnostic accuracy of heart rhythm disorders, excluding atrial fibrillation.
arm group label: Group 1 - Smartwatch - single lead (D1)
description: To obtain the automatic electrocardiographic diagnosis of the clock, two ECG tracings of 30 seconds will be obtained, in a calm environment, with the patient at rest, in the horizontal supine position. The device will be attached to the wrist on the left side with the use of the fingers of the right hand on the sensor button of the watch to complete the electrocardiographic DI derivation following the Einthoven triangle derivation criteria. The automatic diagnosis obtained must be the same in both plots to be validated. The specific results of the automatic diagnosis obtained by the watch will be: low beats with FC≤40 beats per minute (bpm); high beats with HR≥120bpm; sinus rhythm when interpreted as normal by the clock, atrial fibrillation, inconclusive and does not allow analysis due to poor technical quality and did not allow tracing.
arm group label: Group 2 - conventional ECG
description: The conventional ECG tracing will be obtained in the 12 leads of the frontal plane (DI, DII, DIII, aVR, AVL, AVF) and the horizontal plane (V1 to V6) and a 30-second rhythm trace in the DI lead. The diagnostic results of conventional ECG tracings will be: normal or abnormal; sinus rhythm, AF, atrial flutter or other non-sinus rhythm; intraventricular conduction disorder: left bundle branch block (BRE), right bundle branch block (BRD), right posteroinferior lower block (BDPI or left anterior superior (BDAS), isolated or associated; normal electrical axis, shifted to the right or shifted to the right) left, inconclusive and does not allow analysis due to poor technical quality.
intervention type: Diagnostic Test
intervention name: Electrocardiogram diagnosis
description: Electrocardiographic diagnosis will be made in a double-blind manner by two specialists in cardiology and cardiac arrhythmias and the results will be compared between the groups studied.
arm group label: Group 1 - Smartwatch - single lead (D1)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos Eduardo B de Lima, MD, PhD
role: Principal Investigator
affiliation: Federal University of Piaui
last name: Carlos Eduardo B. Lima, MD, PhD
phone: +5586981805000
email: carlos.lima@ufpi.edu.br
last name: Carlos Eduardo B. Lima, MD, PhD
phone: +55863085-3048
email: cardiolima.medicalcenter@hotmail.com.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
citation: Lima C, Martinelli M, Peixoto GL, Siqueira SF, Wajngarten M, Silva RT, Costa R, Filho R, Ramires JA. Silent Atrial Fibrillation in Elderly Pacemaker Users: A Randomized Trial Using Home Monitoring. Ann Noninvasive Electrocardiol. 2016 May;21(3):246-55. doi: 10.1111/anec.12294. Epub 2015 Sep 28.
PMID: 26413928
responsible party type: Principal Investigator
investigator affiliation: Federal University of Piaui
investigator full name: Carlos Eduardo Batista de Lima, MD, PhD
investigator title: Professor of Medicine (Cardiology)
mesh term: Cardiovascular Diseases
mesh term: Arrhythmias, Cardiac
mesh term: Cardiac Conduction System Disease
sharing ipd: No
ipd description: I have no plan to share individual patient data with other researchers.