Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-05 @ 4:11 AM
Study NCT ID:
NCT02562534
Status:
TERMINATED
Last Update Posted:
2021-07-02
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creation of an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'There was sufficient data to verify the primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the ECG signal quality', 'timeFrame': 'One year', 'description': 'Evaluation of the ECG signal quality acquired in the MRI 3 Tesla by measuring the amplitude of the QRS complex (in millivolts). Conformity with IEC (International Electrotechnical Commission) 60601-2-51 standard.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ECG', 'MRI', 'rhythm troubles', 'conductive troubles', 'ECG artifacts', 'Database'], 'conditions': ['Heart Diseases']}, 'descriptionModule': {'briefSummary': 'The aim is to create a database including recordings of ECG data recorded in an MRI acquisition', 'detailedDescription': 'ECG monitoring is an essential tool during MRI, especially for cardiac MRI (CMR). Indeed, the system needs to synchronize the acquisitions on the cardiac cycles. To identify the cycle, the system is based on the ECG. Furthermore, patients having a CMR can be at risk of presenting cardiac rhythm troubles, and must be monitored with a trustable system.\n\nThe problem is that in MRI, a lot of artefacts occur, leading to dramatic disturbances of the signal. A lot of tools are used to try to remove the artefacts. The aim of this study is to create a database that can be used to test the different tools to remove the artefacts.\n\nThe investigators intend to include all types of ECG patterns that can exist, to allow to test the tools in all situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For all subjects:\n\n * To be more than 18\n * To be enroled in a social security plan\n * To have signed an informed consent\n * To have preliminary medical examination\n* For the groups :\n\n * "normal ECG" group : sinus rhythm without conductive troubles. Normal pattern of the QRS\n * "conductive troubles group" : patients with typical right bundle branch block, or typical left bundle branch block pattern.\n * "rhythm trouble group" : patients with premature atrial beats or premature ventricular beats\n\nExclusion Criteria:\n\n* Contraindication: implantable devices (cardiac stimulators, defibrillators, cochlear implants, etc.), metallic foreign bodies\n* Impossibility to undergo MRI: claustrophobia, morbid obesity.\n* Pregnancy or risk of pregnancy.\n* Patients under a measure of legal protection'}, 'identificationModule': {'nctId': 'NCT02562534', 'acronym': 'DB-ECG-3T', 'briefTitle': 'Creation of an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Use of a New ElectroCardioGraph to Create an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease in Order to Let go of Artifacts.', 'orgStudyIdInfo': {'id': '2012-A01406-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with conductive troubles', 'description': 'Patients with conductive troubles', 'interventionNames': ['Device: MRI compatible ElectroCardioGraph']}, {'type': 'OTHER', 'label': 'Patients with rhythm troubles', 'description': 'Patients with rhythm troubles', 'interventionNames': ['Device: MRI compatible ElectroCardioGraph']}, {'type': 'OTHER', 'label': 'Volunteers', 'description': 'Volunteers with normal ECG', 'interventionNames': ['Device: MRI compatible ElectroCardioGraph']}], 'interventions': [{'name': 'MRI compatible ElectroCardioGraph', 'type': 'DEVICE', 'description': 'MRI with ECG control for people with healthy heart or heart diseases', 'armGroupLabels': ['Patients with conductive troubles', 'Patients with rhythm troubles', 'Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Christian De Chillou, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist specialised in rhythmology', 'investigatorFullName': 'Dr Jean-Marc SELLAL', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}