NCT05206825

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

January 12, 2022

Last Update Submit

July 18, 2022

Conditions

Cardiac Arrhythmia

Keywords

ElectrocardiogramMobile ECG

Outcome Measures

Primary Outcomes (2)

  • ECG Tracing Quality

    Evaluation of quality of ECG tracings obtained with different electrocardiographs

    Once: Day 0-3 after entry to the study.

  • Cardiac Rhythm Determination

    Defining a rhythm of the patient based on recorder tracings.

    Once: Day 0-3 after entry to the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cardiac diseases,hospitalized in Department of Electrocardiology Medical University of Lodz as well as healthy volunteers will be enrolled to the study.

You may qualify if:

  • 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)

You may not qualify if:

  • Not willing or incapable to give written informed consent.
  • Lack of willingness to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Electrocardiology Medical University of Lodz

Lodz, 93-216, Poland

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 25, 2022

Study Start

January 2, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

July 19, 2022

Record last verified: 2022-01

Locations

PL(1)