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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206825
• Other study ID #: RNN/172/20/KE
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

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.