Clinical trial NCT03351660: CardioSecur Connected Electrocardiography in General Care
Official title: Diagnostic Value of the CardioSecur Connected EcG in General Care: The Connected EGG-study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Connected ECG
Family Practice
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients consulting a family doctor and presenting clinical manifestions of heart disease

Brief 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.

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Performance of ECG Cardiosecur
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aire-sur-la-Lys
country: France
city: Chenôve
country: France
city: Cysoing
country: France
city: Dijon
country: France
city: Iteuil
country: France
city: Montreuil-sur-mer
country: France
city: Poitiers
country: France
city: Roubaix
country: France
city: Vervins
country: France
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Aymeric Menet, MD
role: PRINCIPAL_INVESTIGATOR
References: