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

July 18, 2022 updated by: Medical University of Lodz
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 93-216
        • Recruiting
        • Department of Electrocardiology Medical University of Lodz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2022

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 12, 2022

First Posted (ACTUAL)

January 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN/172/20/KE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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