NCT03351660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

2.3 years

First QC Date

November 20, 2017

Last Update Submit

April 4, 2022

Conditions

Heart DiseasesConnected ECGFamily Practice

Outcome Measures

Primary Outcomes (1)

  • Performance of ECG Cardiosecur

    Proportion of correct diagnosis before and after Cardiosecur

    Baseline

Interventions

connected ECGDIAGNOSTIC_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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Aire-sur-la-Lys, 62120, France

Location

Unknown Facility

Chenôve, 21300, France

Location

Unknown Facility

Cysoing, 59830, France

Location

Unknown Facility

Dijon, 21600, France

Location

Unknown Facility

Iteuil, 86240, France

Location

Unknown Facility

Montreuil-sur-Mer, 62170, France

Location

Unknown Facility

Poitiers, 86440, France

Location

Unknown Facility

Roubaix, 59100, France

Location

Unknown Facility

Vervins, 02140, France

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Aymeric Menet, MD

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 24, 2017

Study Start

December 15, 2016

Primary Completion

March 28, 2019

Study Completion

March 28, 2019

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)