Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT04357405
Status:
TERMINATED
Last Update Posted:
2022-09-29
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of teletransmetted electrocardiogram (ECG) feasability (number of ECGs interpretable)', 'timeFrame': '12 months', 'description': 'An interpretable ECG is defined by an absence of parasite, a stable baseline, an absence of argument of a malposition of electrodes, an unwinding paper speed: 25 mm / sec, a calibration of the amplitude'}, {'measure': 'Assessment of prevalence of anomalies highlighted by performing an electrocardiogram.', 'timeFrame': '12 months', 'description': 'The prevalence of anomalies highlighted by performing an electrocardiogram: supra-ventricular rhythm disorders, ventricular rhythm disorder and coronary pathologies.'}], 'secondaryOutcomes': [{'measure': 'Assessment of commorbidity risk and life expectancy according Charlson score.', 'timeFrame': '12 months'}, {'measure': 'Assessment of prevalence of unknown and iatrogenic anomalies according to the electrocardiogram', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECG', "Elderly EHPAD's resident", 'Cardiac desease'], 'conditions': ['Cardiac Pathology', 'Residents of Retirement Home (EHPAD)']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.', 'detailedDescription': 'Main objectives :\n\n* Evaluate the workability of ECG uploaded by a caregiver who was trained before\n* Evaluate the prevalence of ECG anomalies highlighted thanks to the realisation of an uploaded ECG (supraventricular and ventricular rhythm disorder and coronary pathology)\n\nSecondaries objectives :\n\n* Evaluate the prevalence of unknown ECG anomalies and thus determine the number of new diagnostics highlighted thanks to uploaded ECG\n* Evaluate the prevalence of ECG iatrogenic anomalies\n\nThe study is observational, multicentre and prospective. It is going to include 3211 elderly living in EHPAD in Île-de-France. 150 EHPAD or involved in the study, they are split in two groups : 100 EHPAD will receive ECG and 50 EHPAD will not. This last group will enable to lead a comparative analysis, only global data about death will be collected.\n\nThe study will last 36 months with 12 months of participation for each resident.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients living in nursing homes (EHPAD) requiring an electrocadiogram (ECG) except emergency situation, due to a cardiac pathology with / or without treatment which can lead to ECG abnormalities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nElderly living in nursing homes (EHPAD) who requires electrocadiogram (ECG) due to :\n\n* Cardiac pathology : coronary artery disease, heart failure, high blood pressure, diabetes, valvular disease, atrial fibrillation\n* A medication which could causes electrocadiogram (ECG) anomalies Patients living in nursing homes (EHPAD) who give their agreement.\n\nExclusion criteria :\n\nProtected adult under a protection of the court'}, 'identificationModule': {'nctId': 'NCT04357405', 'acronym': 'TEECAD', 'briefTitle': 'Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.', 'organization': {'class': 'OTHER', 'fullName': "Gérond'if"}, 'officialTitle': 'Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.', 'orgStudyIdInfo': {'id': '2017-A02647-46'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental arm', 'description': 'This group consists of 100 EHPAD which will benefit from ECG teletransmission. all data will be collected'}, {'label': 'Control arm', 'description': 'This arm consists of 50 EHPAD that have not benefited from ECG teletransmission. Only the global death occurrence data will be analyzed, no individual data will be collected.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Psychiatric Geriatric Department, Broca hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Olivier Hanon, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Psychiatric Geriatric Department, Broca hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gérond'if", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}