Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-29 @ 10:15 AM
Study NCT ID:
NCT06878768
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translational Research GRICS-CineCardiac
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative image reading by the radiologist', 'timeFrame': '1 Month', 'description': 'Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire'}, {'measure': 'Quantitative image analysis by the radiologist', 'timeFrame': '1 Month', 'description': 'Feasibility of GRICS CardioCine : the radiologist responds to a questionnaire'}], 'secondaryOutcomes': [{'measure': 'Right ventricular end-diastolic volume', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Left ventricular end-diastolic volume', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Right ventricular end-systolic volume', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Left ventricular end-systolic volume', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Right ventricular systolic ejection volume', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Left ventricular systolic ejection volume', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Right ventricular ejection fractions', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Left ventricular ejection fractions', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Left ventricular mass in diastole', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Aortic flow', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}, {'measure': 'Analysis of the segmental kinetics of the left ventricle', 'timeFrame': 'Day 1', 'description': 'Free-breathing and breath-hold measurements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Feasibility of GRICS CardioCine on Patients with Ischemic or Dilated Cardiopathy']}, 'descriptionModule': {'briefSummary': 'This project is a pilot study which aims at showing the feasibility of free breathing cardiac MRI using GRICS (Generalized Reconstruction by Inversion of Coupled System)software in a clinical environment.\n\nThe GRICS technique has been developed by the IADI (Diagnostic, Adaptive and Interventional Imaging)lab, Nancy, France. It enables free breathing MRI thanks to a reconstruction algorithm which provides artefact-free images based on raw MR data and physiological data from external sensors (respiratory belts, ECG.\n\nIn this study, we want to acquire free breathing cardiac cine images during a standard cardiac MR exam and compare those data with the breath-hold ones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* candidate to cardiac MR exam because of ischemic or dilated cardiopathy\n* legally an adult\n* having heath insurance\n* having signed the consent form\n\nExclusion Criteria:\n\n* dyspnea\n* atrial fibrillation\n* pain while lying on the back for a long time\n* inability to follow a procedure\n* contraindication to MRI\n* contraindication to gadolinium chelate injection'}, 'identificationModule': {'nctId': 'NCT06878768', 'briefTitle': 'Translational Research GRICS-CineCardiac', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Imagerie Cardiaque Ciné Par Résonance Magnétique En Respiration Libre', 'orgStudyIdInfo': {'id': 'C10-04'}, 'secondaryIdInfos': [{'id': '2010-A00789-30', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'interventionNames': ['Device: Additional free breathing MR acquisitions']}], 'interventions': [{'name': 'Additional free breathing MR acquisitions', 'type': 'DEVICE', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}