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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05206825

Enrollment

300

Registered

2022-01-25

Start date

2022-01-02

Completion date

2023-12-01

Last updated

2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

Keywords

Electrocardiogram, Mobile ECG

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Poland

Outcome results