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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05206825
Other study ID # RNN/172/20/KE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2022
Est. completion date December 1, 2023

Study information

Verified date January 2022
Source Medical University of Lodz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.


Description:

Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording. ECG evaluation will include: rhythm description, measurements of mean RR, PR, QRS, QT, QTc and ST-T description. Additionally inter/intraventricular conduction abnormalities are to be determined from 12-leads ECG and approximate from mobile ECG recordings.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 1, 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with indication for electrocardiography - Informed consent to participate in the study - The possibility of self-registration of a mobile ECG (no physical and mental restrictions) Exclusion Criteria: - Not willing or incapable to give written informed consent. - Lack of willingness to cooperate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Poland Department of Electrocardiology Medical University of Lodz Lodz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary ECG Tracing Quality Evaluation of quality of ECG tracings obtained with different electrocardiographs Once: Day 0-3 after entry to the study.
Primary Cardiac Rhythm Determination Defining a rhythm of the patient based on recorder tracings. Once: Day 0-3 after entry to the study.
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