Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-19 @ 5:44 AM
Study NCT ID:
NCT02848703
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2016-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study " COFLORES "
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2016-07-26', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial perfusion', 'timeFrame': '1day', 'description': 'MRI based on the magnetic labeling of arterial spins'}], 'secondaryOutcomes': [{'measure': 'the myocardial energetic status', 'timeFrame': '1day', 'description': 'using phosphorus-31 Magnetic Resonance Spectroscopy'}, {'measure': 'the myocardial sodium', 'timeFrame': '1day', 'description': 'using sodium-23 MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myocardial Perfusion']}, 'descriptionModule': {'briefSummary': 'Myocardial perfusion is a major parameter characterizing the status of capillary circulation of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI) during the 1st pass of a contrast agent through the capillary system. This technique is radiation-free, but it is difficult to repeat measurements during a single exam. Also, a number of patients suffering from cardiac disease cannot receive contrast agent injections. The investigators have developed a totally non-invasive approach for quantifying myocardial perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the capillaries (Arterial spin labeling, ASL).\n\nGoal : The major goal of this research protocol is to validate a totally non-invasive method of myocardial blood flow quantification using MRI without contrast agent injection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People having no heart disease or treatment referred to cardiology\n* People having no cons -indications to MRI\n* People having no cons -indications to gadolinium ;\n* People not wearing implantable devices\n* People not wearing metallic foreign bodies or risk (eg . Business of steel, etc .. )\n* People having no cardiovascular risk factor\n* Person subject to the social security scheme\n* Nobody agreeing to participate in the study and who signed the informed consent\n\nExclusion Criteria:\n\n* Refusal to go spontaneous or MRI because of claustrophobia important\n* Trouble rhythm making MRI uninterpretable'}, 'identificationModule': {'nctId': 'NCT02848703', 'briefTitle': 'Study " COFLORES "', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Study " COFLORES ":Imaging of Coronary Reserve Without Tracers', 'orgStudyIdInfo': {'id': '2015-45'}, 'secondaryIdInfos': [{'id': '2016-A00026-45', 'type': 'REGISTRY', 'domain': 'ansm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy volunteers', 'interventionNames': ['Device: Magnetic Resonance Imaging (MRI)', 'Device: phosphorus-31 Magnetic Resonance Spectroscopy', 'Device: sodium-23 MRI']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'DEVICE', 'armGroupLabels': ['healthy volunteers']}, {'name': 'phosphorus-31 Magnetic Resonance Spectroscopy', 'type': 'DEVICE', 'armGroupLabels': ['healthy volunteers']}, {'name': 'sodium-23 MRI', 'type': 'DEVICE', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Catherine GEINDRE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}