[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396116":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":58,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":73,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Federal University of Piaui","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Smartwatch - single lead (D1)",null,"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.",[13],"Diagnostic Test: Electrocardiogram diagnosis",{"label":15,"type":10,"description":16,"interventionNames":10},"Group 2 - conventional ECG","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.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DIAGNOSTIC_TEST","Electrocardiogram diagnosis","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.",[9],[24],{"name":25,"affiliation":5,"role":26},"Carlos Eduardo B de Lima, MD, PhD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Carlos Eduardo B. Lima, MD, PhD","CONTACT","+5586981805000","carlos.lima@ufpi.edu.br",{"name":29,"role":30,"phone":34,"phoneExt":10,"email":35},"+55863085-3048","cardiolima.medicalcenter@hotmail.com.br",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Carlos Eduardo B. de Lima","RECRUITING","Teresina","Piauí","64048-350","Brazil","BR",{"type":46,"coordinates":47},"Point",[48,49],-42.80194,-5.08917,{"lat":49,"lon":48},[52,54],{"name":25,"role":30,"phone":53,"phoneExt":10,"email":32},"86981805000",{"name":55,"role":30,"phone":56,"phoneExt":10,"email":57},"Amanda Sousa","86994615203","admin@cardiolima.com.br",{"type":26,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Carlos Eduardo Batista de Lima, MD, PhD","Professor of Medicine (Cardiology)","100396116","accuracy-of-cardiac-arrhythmias-and-conduction-disorders-diagnosis-using-a-smartwatch-100396116",false,"NCT04437914","Accuracy of Cardiac Arrhythmias and Conduction Disorders Diagnosis Using a Smartwatch","Accuracy of Cardiac Arrhythmias and Conduction Disorders Diagnosis Using Smartwatch in Comparison to Conventional Electrocardiogram in Patients With Cardiovascular Disease","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Withdrawal of the consent form at the request of the patient or guardian.","ALL","18 Years",{"count":71,"type":72},110,"ESTIMATED","6 Months","OBSERVATIONAL","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.",[77,78,79],"Cardiovascular Diseases","Cardiac Arrhythmia","Conduction Disturbance",[81,78,82,83],"Artificial Intelligence","Smartwatch","Cardiac Conduction System Disturbance","2024-09-24",{"date":86,"type":87},"2024-09-25","ACTUAL",{"date":89,"type":87},"2021-06-07",{"date":91,"type":72},"2025-06-30",{"name":5,"class":6},1]