Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 6:57 AM
Study NCT ID:
NCT06781034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2025-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of spot sign on gadolinium MRI', 'timeFrame': 'baseline', 'description': 'Presence of spot sign on gadolinium MRI (Yes/No)'}, {'measure': 'Morphologic description of gadolinium MRI spot sign', 'timeFrame': 'baseline', 'description': 'morphological (shape, location within the hematoma) description of spot signs on brain MRI'}, {'measure': 'Quantitative description of gadolinium MRI spot sign', 'timeFrame': 'baseline', 'description': 'Quantitative (number and categorial) description of spot signs on brain MRI'}], 'secondaryOutcomes': [{'measure': 'association of spot sign with hematoma expansion on follow-up CT', 'timeFrame': 'Baseline', 'description': 'association of spot sign with hematoma expansion on follow-up CT(Yes/No)'}, {'measure': 'Association with the underlaying pathology', 'timeFrame': 'Baseline', 'description': 'Association with the underlaying pathology as identified by the authors (Yes/No)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral haemorrhage', 'MRI'], 'conditions': ['Cerebral Hemorrhage', 'Acute Lobar Haematoma']}, 'descriptionModule': {'briefSummary': 'Cerebral haemorrhage represents a minority of acute vascular syndromes (less frequent than ischemic stroke, at around 20%), but with a therapeutic impasse, having no specific treatment.\n\nArterial contrast ("spot sign") within the hematoma has been described in CT scans as a risk factor for further enlargement and poor prognosis.\n\nAn equivalent marker has also been described in gadolinium-enhanced MRI.\n\nBy studying the radiological appearance of gadolinium "spot signs" on MRI, which has better parenchymal resolution, the researchers propose to retrace the phenomenology of the acute phase of cerebral hemorrhage in order to better estimate the risk of radiological aggravation by subgroup, which could serve as a target population for future therapeutic trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute cerebral hematoma from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy; who underwent a follow-up cerebral CT scan in the event of worsening or for follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute cerebral hematomas from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy managed at Nîmes University Hospital;\n* Patients who have undergone a follow-up cerebral CT scan in the event of worsening or for follow-up.\n\nExclusion Criteria:\n\n* Patient refusing to participate'}, 'identificationModule': {'nctId': 'NCT06781034', 'acronym': 'GADO-ICH', 'briefTitle': 'Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies', 'orgStudyIdInfo': {'id': 'Local/2024/TP-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with acute lobar and deep haematoma', 'description': 'None, pure observational study', 'interventionNames': ['Other: None, pure observational study']}], 'interventions': [{'name': 'None, pure observational study', 'type': 'OTHER', 'description': 'None, pure observational study', 'armGroupLabels': ['patients with acute lobar and deep haematoma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Teodora PARVU', 'role': 'CONTACT', 'email': 'teodora.parvu@chu-nimes.fr', 'phone': '04.66.68.32.61'}], 'overallOfficials': [{'name': 'Anissa MEGZARI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}