CardioSecur Connected Electrocardiography in General Care (CARDIOSECUR)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Connected ECG; Family Practice
• Intervention / Treatment: Diagnostic test: connected ECG

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 338

Contacts and Locations

Study Locations

• France
  • Aire-sur-la-Lys, France, 62120
  • Chenôve, France, 21300
  • Cysoing, France, 59830
  • Dijon, France, 21600
  • Iteuil, France, 86240
  • Montreuil-sur-mer, France, 62170
  • Poitiers, France, 86440
  • Roubaix, France, 59100
  • Vervins, France, 02140

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults patients consulting a family doctor and presenting clinical manifestions of heart disease

Description

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:

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of ECG Cardiosecur	Proportion of correct diagnosis before and after Cardiosecur	Baseline

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Aymeric Menet, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: RCP-0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No