Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT04241757
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
2019-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrocardiogram in General Practice : the EGG Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 888}, 'patientRegistry': False}, 'statusModule': {'whyStopped': '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.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of clinical signs', 'timeFrame': 'day 0', 'description': 'Prevalence of each clinical sign within each Electrocardiogram indication'}, {'measure': 'Description of clinical signs ElectroCardioGram (ECG) sign', 'timeFrame': 'day 0', 'description': 'Prevalence of each sign on the Electrocardiogram within each indication.'}], 'secondaryOutcomes': [{'measure': 'Difficulties in carrying out the Electrocardiogram', 'timeFrame': 'Day 0', 'description': 'Duration of the Electrocardiogram (minutes) Measured by average duration of the ECG, prevalence of the difficulties of realization and interpretation mentioned by the investigators.'}, {'measure': 'Initial management types', 'timeFrame': 'Months 1', 'description': 'Prevalence of initial management types (certificate, medication, addressing) at 1 month.'}, {'measure': 'Diagnosis types', 'timeFrame': 'Months 1', 'description': 'Prevalence of diagnosis types at 1 month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ElectroCardioGram', 'General practice', 'Diagnosis', 'Signs and symptoms', 'Feasibility studies'], 'conditions': ['Indication for ElectroCardioGram']}, 'descriptionModule': {'briefSummary': '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.\n\nDescribing 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.', 'detailedDescription': 'The primary objective of this study is to describe the clinical signs and ElectroCardioGram (ECG) in situations indicating an ElectroCardioGram (ECG) in general practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with indication of ElectroCardioGram (ECG) will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient consulting one of the generalist practitioner investigators\n* In doctor's office or at home, scheduled or not,\n* During normal surgery hours or out-of-hours service,\n* Whatever the reason for consultation,\n* Aged 18 years or older,\n* 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\n\nExclusion Criteria:\n\n* ElectroCardioGram (ECG) not performed due to emergency context\n* Patient with cognitive impairment who cannot give consent to participate in the study and / or patient under guardianship"}, 'identificationModule': {'nctId': 'NCT04241757', 'acronym': 'EGG', 'briefTitle': 'Electrocardiogram in General Practice : the EGG Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Electrocardiogram in General Practice : the EGG Study', 'orgStudyIdInfo': {'id': 'IRBN432019/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with indication of ElectroCardioGram (ECG)', 'description': 'Patient with indication of ElectroCardioGram (ECG) will be included. They will have a collection of results ElectroCardioGram (ECG).', 'interventionNames': ['Diagnostic Test: ElectroCardioGram (ECG)']}], 'interventions': [{'name': 'ElectroCardioGram (ECG)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Collection of results ElectroCardioGram (ECG).', 'armGroupLabels': ['Patient with indication of ElectroCardioGram (ECG)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Association CNGE IRMG', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Paul FRAPPE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU DE SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association CNGE IRMG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}