Indication for ElectroCardioGramEGGNCT04241757
Electrocardiogram in General Practice : the EGG Study
An observational study of Indication for ElectroCardioGram, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication for ElectroCardioGram
- What is being tested?
- ElectroCardioGram (ECG)
- How many people
- 888 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2019to 19 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with indication of ElectroCardioGram (ECG) will be included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Indication for ElectroCardioGram
- Being tested
- ElectroCardioGram (ECG)
- Keywords
- ElectroCardioGram, General practice, Diagnosis, Signs and symptoms, Feasibility studies
- Medical subject headings
- Disease, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroCardioGram (ECG)Diagnostic test
Collection of results ElectroCardioGram (ECG).
| Study group | Role | What they receive |
|---|---|---|
| Patient with indication of ElectroCardioGram (ECG) | Patient with indication of ElectroCardioGram (ECG) will be included. They will have a collection of results ElectroCardioGram (ECG). Receives: Diagnostic Test: ElectroCardioGram (ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of clinical signs
Prevalence of each clinical sign within each Electrocardiogram indication
Measured: day 0
Description of clinical signs ElectroCardioGram (ECG) sign
Prevalence of each sign on the Electrocardiogram within each indication.
Measured: day 0
Secondary outcomes (3)
Difficulties in carrying out the Electrocardiogram
Duration of the Electrocardiogram (minutes) Measured by average duration of the ECG, prevalence of the difficulties of realization and interpretation mentioned by the investigators.
Measured: Day 0
Initial management types
Prevalence of initial management types (certificate, medication, addressing) at 1 month.
Measured: Months 1
Diagnosis types
Prevalence of diagnosis types at 1 month.
Measured: Months 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start17 Sep 2019
- Primary completion1 Oct 2021
- Study completion19 Nov 2021
Why it stopped: The EGG study is no longer in progress, as the association that carried it out (IRMG) has had to close due to the impact of the Covid crisis on continuing education.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for ElectroCardioGramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Association CNGE IRMG
- Responsible party
- Sponsor
- Investigators
- Paul FRAPPE, MD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241757
- Sponsor's protocol ID
- IRBN432019/CHUSTE
- Acronym
- EGG
- Status last verified
- Jun 2023
- First submitted
- 18 Nov 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiogram in General Practice : the EGG Study
- ClinicalTrials.gov ID
- NCT04241757
- Acronym / sponsor ID
- EGG / IRBN432019/CHUSTE
- Conditions
- Indication for ElectroCardioGram
- Keywords
- ElectroCardioGram, General practice, Diagnosis, Signs and symptoms, Feasibility studies
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The EGG study is no longer in progress, as the association that carried it out (IRMG) has had to close due to the impact of the Covid crisis on continuing education.
- Enrolment
- 888 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Association CNGE IRMG
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with indication of ElectroCardioGram (ECG) | – | Diagnostic Test: ElectroCardioGram (ECG)Patient with indication of ElectroCardioGram (ECG) will be included. They will have a collection of results ElectroCardioGram (ECG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with indication of ElectroCardioGram (ECG) will be included.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroCardioGram (ECG)Collection of results ElectroCardioGram (ECG). | Diagnostic test | Patient with indication of ElectroCardioGram (ECG) |
Primary outcome
Description of clinical signs
Time frame: day 0
Prevalence of each clinical sign within each Electrocardiogram indication
Description of clinical signs ElectroCardioGram (ECG) sign
Time frame: day 0
Prevalence of each sign on the Electrocardiogram within each indication.
3 secondary outcomes
Difficulties in carrying out the Electrocardiogram
Time frame: Day 0
Initial management types
Time frame: Months 1
Diagnosis types
Time frame: Months 1
Results and safety
The study was stopped early (reason given: The EGG study is no longer in progress, as the association that carried it out (IRMG) has had to close due to the impact of the Covid crisis on continuing education.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul FRAPPE, MD principal investigator
CHU DE SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indication for ElectroCardioGram, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The EGG study is no longer in progress, as the association that carried it out (IRMG) has had to close due to the impact of the Covid crisis on continuing education.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of clinical signs (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.