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Electrocardiogram in General Practice : the EGG Study (EGG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241757
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Association CNGE IRMG
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Indication for ElectroCardioGram Diagnostic Test: ElectroCardioGram (ECG)

Detailed Description:
The primary objective of this study is to describe the clinical signs and ElectroCardioGram (ECG) in situations indicating an ElectroCardioGram (ECG) in general practice.

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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Electrocardiogram in General Practice : the EGG Study
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Group/Cohort Intervention/treatment
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)
Collection of results ElectroCardioGram (ECG).




Primary Outcome Measures :
  1. Description of clinical signs [ Time Frame: day 0 ]
    Prevalence of each clinical sign within each Electrocardiogram indication

  2. Description of clinical signs ElectroCardioGram (ECG) sign [ Time Frame: day 0 ]
    Prevalence of each sign on the Electrocardiogram within each indication.


Secondary Outcome Measures :
  1. Difficulties in carrying out the Electrocardiogram [ Time Frame: Day 0 ]
    Duration of the Electrocardiogram (minutes) Measured by average duration of the ECG, prevalence of the difficulties of realization and interpretation mentioned by the investigators.

  2. Initial management types [ Time Frame: Months 1 ]
    Prevalence of initial management types (certificate, medication, addressing) at 1 month.

  3. Diagnosis types [ Time Frame: Months 1 ]
    Prevalence of diagnosis types at 1 month.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with indication of ElectroCardioGram (ECG) will be included.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241757


Contacts
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Contact: Paul FRAPPE, MD (0)477421416 paul.frappe@univ-st-etienne.fr
Contact: Béatrice DEYGAS, CRA (0)477127655 ext +33 beatrice.deygas@chu-st-etienne.fr

Locations
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France
Association CNGE IRMG Recruiting
Saint-Étienne, France
Principal Investigator: Paul FRAPPE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Association CNGE IRMG
Investigators
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Principal Investigator: Paul FRAPPE, MD CHU DE SAINT-ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04241757    
Other Study ID Numbers: IRBN432019/CHUSTE
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
ElectroCardioGram
General practice
Diagnosis
Signs and symptoms
Feasibility studies