Accuracy of Cardiac Arrhythmias and Conduction Disorders Diagnosis Using a Smartwatch

StatusUnknown
PhaseNot specified
Started

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Primary completion date: Aug 30, 2023 to Aug 30, 2024
    • Study completion date: Jun 30, 2024 to Jun 30, 2025
    v7
  3. Minor Site contact updatedv6
  4. Notable Primary completion date: May 10, 2022 to Aug 30, 2023
    • Study completion date: Dec 31, 2022 to Jun 30, 2024
    v5
  5. Notable Primary completion date: Jun 7, 2021 to May 10, 2022
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    • Site contact updated
    v4
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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Start date changed from estimate of Aug 1, 2020 to Jun 7, 2021
    • Study sites: 0 to 1
    • Primary completion date changed from estimate of Feb 28, 2021 to Jun 7, 2021
    • Study completion date: Aug 31, 2021 to Dec 31, 2021
    • Publications: 4 to 1
    • Study description shortened, about 3 words
  2. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04437914
Lead Sponsor Federal University of Piaui
Conditions
(from sponsor)
Cardiovascular Diseases, Cardiac Arrhythmia, Conduction Disturbance
Related terms Arrhythmias, Cardiac, Cardiovascular Diseases
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov