Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT05206825
• Lead Sponsor: Medical University of Lodz

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-02
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-25
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19
• Primary Completion: 2023-06
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ECG Tracing Quality	Once: Day 0-3 after entry to the study.	Evaluation of quality of ECG tracings obtained with different electrocardiographs
Cardiac Rhythm Determination	Once: Day 0-3 after entry to the study.	Defining a rhythm of the patient based on recorder tracings.

Trial Locations

Locations (1)

Department of Electrocardiology Medical University of Lodz; 🇵🇱 Lodz, Poland