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Completed

NCT Number: NCT03351660

CardioSecur Connected Electrocardiography in General Care

Heart disease symptoms are a frequent reason of consultation in general medical practice. Only a few general practitioners are equipped with a 12 lead Electrocardiography (ECG) whereas this test is extremely useful for diagnosis orientation in cases of cardiac diseases.Cardiosecur allows the realization of a 15 or 22 leads ECG with only 4 electrodes connected to a smartphone or a tablet with an automatic interpretation function. The goal of the study is to evaluate the diagnostic value of Cardiosecur device regarding cardiac symptoms in family practice.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aire-sur-la-Lys, France

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About this study

This study will be a multicenter, single arm, non randomized trial testing the incremental diagnosis value of Cardiosecur ECG regarding cardiac disease in general care.

Ten general practitioners will be given a Cardiosecure ACTIVE device with a tablet and perform an EKG to their consecutive patients who meet the inclusion criteria.

Inclusion criteria

  • Recent cardiovascular symptom < 7 days (chest pain, dyspnea, palpitation, heart failure or transient loss of consciousness) or physical examination leading in possible cardiac cause.
  • Aged over 18 years
  • signed the informed consent
  • A questionnaire regarding the diagnosis orientation based on the patients' symptoms and physical examination will be given to GPs before and after the ECG realization and automatic interpretation to evaluate whether the ECG modified the diagnosis.

If the GP need further exploration to conclude or if the patient is oriented to an hospital or a specialist, the reference diagnosis will be defined at the end of these explorations. Otherwise, the diagnostic will be defined at the end of the GP consultation.

  • A questionnaire regarding the ease of use of the Cardiosecure device will be filled by the patients.
  • Time for ECG realization will be recorded.
  • All the ECG and their automatic interpretation will be stored anonymously according to bioethics laws and then reviewed by 2 experienced cardiologists blinded to the results of the automatic interpretation. The interobserver reproducibility as well as the comparison with the Cardiosecur automatic interpretation will be analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recent cardiovascular symptoms < 7 days (chest pain, dyspnea, palpitations, heart failure or transient loss of consciousness) or physical examination suggesting cardiac disease.
  • Patients aged over 18 years
  • Signed the informed consent

Exclusion criteria

Treatment and study plan

connected ECG

Diagnostic Test

Cardiosecur allows the realization of a 15 or 22 leads ECG with only 4 electrodes connected to a tablet with an automatic interpretation function

Primary outcomes

  1. Performance of ECG Cardiosecur

    Time frame: Baseline

    Proportion of correct diagnosis before and after Cardiosecur

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Diagnostic Value of the CardioSecur Connected EcG in General Care: The Connected EGG-study.

Acronym: CARDIOSECUR

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2017
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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