CardioSecur Connected Electrocardiography in General Care

Heart Diseases Clinical Trial

— CARDIOSECUR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351660
• Other study ID #: RCP-0063
• Status: Completed
• Start date: December 15, 2016
• Est. completion date: March 28, 2019

Study information

• Verified date: April 2022
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Connected ECG
• Family Practice
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of ECG Cardiosecur	Proportion of correct diagnosis before and after Cardiosecur	Baseline