NCT04241757

Brief Summary

Existing resources to assist interpretation of ElectroCardioGram (ECG) in general practice provide specialized and comprehensive reading based on pathologies and ElectroCardioGram (ECG) signs rather than ElectroCardioGram (ECG) indications. Describing practices in general medicine could help prioritize the relevance of clinical and ECG signs for the general practitioner, enabling to adjust the reading given the context.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
888

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

September 17, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

November 18, 2019

Last Update Submit

June 19, 2023

Conditions

Keywords

ElectroCardioGramGeneral practiceDiagnosisSigns and symptomsFeasibility studies

Outcome Measures

Primary Outcomes (2)

  • Description of clinical signs

    Prevalence of each clinical sign within each Electrocardiogram indication

    day 0

  • Description of clinical signs ElectroCardioGram (ECG) sign

    Prevalence of each sign on the Electrocardiogram within each indication.

    day 0

Secondary Outcomes (3)

  • Difficulties in carrying out the Electrocardiogram

    Day 0

  • Initial management types

    Months 1

  • Diagnosis types

    Months 1

Study Arms (1)

Patient with indication of ElectroCardioGram (ECG)

Patient with indication of ElectroCardioGram (ECG) will be included. They will have a collection of results ElectroCardioGram (ECG).

Diagnostic Test: ElectroCardioGram (ECG)

Interventions

Collection of results ElectroCardioGram (ECG).

Patient with indication of ElectroCardioGram (ECG)

Eligibility Criteria

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

Patient with indication of ElectroCardioGram (ECG) will be included.

You may qualify if:

  • Patient consulting one of the generalist practitioner investigators
  • In doctor's office or at home, scheduled or not,
  • During normal surgery hours or out-of-hours service,
  • Whatever the reason for consultation,
  • Aged 18 years or older,
  • Having an indication of ElectroCardioGram (ECG) and/or request certificate of non-contra-indication to the practice of physical activity certificate of non-contra-indication to the practice of physical activity

You may not qualify if:

  • ElectroCardioGram (ECG) not performed due to emergency context
  • Patient with cognitive impairment who cannot give consent to participate in the study and / or patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Association CNGE IRMG

Saint-Etienne, France

Location

MeSH Terms

Conditions

DiseaseSigns and Symptoms

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Paul FRAPPE, MD

    CHU DE SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

January 27, 2020

Study Start

September 17, 2019

Primary Completion

October 1, 2021

Study Completion

November 19, 2021

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations