Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT06309069
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcified aortic brachiocephalic', 'timeFrame': 'baseline', 'description': 'looking for calcified aortic brachiocephalic (presence or absence)'}, {'measure': 'cardiovascular risk', 'timeFrame': 'baseline', 'description': 'Study of cardiovascular risk factors (presence or absence)'}, {'measure': 'history of stroke', 'timeFrame': 'baseline', 'description': 'Presence of a history of stroke (y/n)'}, {'measure': 'Population', 'timeFrame': 'baseline', 'description': 'demographic characteristics age (years)'}, {'measure': 'Population', 'timeFrame': 'baseline', 'description': 'demographic characteristics sexe (M/F)'}, {'measure': 'history of surgical/endovascular cardiovascular intervention', 'timeFrame': 'baseline', 'description': 'surgical/endovascular cardiovascular intervention (y/n)'}, {'measure': 'NIHSS', 'timeFrame': 'baseline', 'description': 'NIHSS score (Score between 1 and 4: minor stroke, Score between 5 and 15: moderate, stroke, Score between 15 and 20: severe stroke) Score \\> 20: severe stroke'}, {'measure': 'calcified aortic arch', 'timeFrame': 'baseline', 'description': 'looking for calcified aortic arch (presence/absence)'}, {'measure': 'calcified carotid', 'timeFrame': 'baseline', 'description': 'looking for calcified carotid (presence/absence)'}, {'measure': 'atherosclerotic plaques', 'timeFrame': 'baseline', 'description': 'looking for atherosclerotic plaques (presence/absence)'}, {'measure': 'calcified aortic valves', 'timeFrame': 'baseline', 'description': 'looking for calcified aortic valves (presence/absence)'}, {'measure': 'calcified mitral valves', 'timeFrame': 'baseline', 'description': 'looking for calcified mitral valves (presence/absence)'}, {'measure': 'CCE diameter', 'timeFrame': 'baseline', 'description': 'CCE diameter measurement (mm)'}, {'measure': 'density', 'timeFrame': 'baseline', 'description': 'CCE density (uh)'}, {'measure': 'involved cerebral artery', 'timeFrame': 'baseline', 'description': 'description of involved cerebral artery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['calcified cerebral embolism', 'cerebral infarction', 'radiological characteristics'], 'conditions': ['Calcified Cerebral Embolism']}, 'referencesModule': {'references': [{'pmid': '35090544', 'type': 'RESULT', 'citation': 'Crouzet L, Gramond A, Suehs C, Fabbro-Peray P, Abbar M, Lopez-Castroman J. Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial. Trials. 2022 Jan 28;23(1):83. doi: 10.1186/s13063-021-05983-2.'}]}, 'descriptionModule': {'briefSummary': 'Calcified cerebral embolism (CCE) is a relatively rare but underdiagnosed cause of infarction. CCE diagnosis is made by CT. Radiological characteristics of CCE have been reported in small case series. The aim of this study was to describe clinical and radiological characteristics of CCE in a large number of patients, and to compare patients with different radiological CCE characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CEE treated with intravenous thrombolysis (IVT) between 2015 and 2020, and patients with AIT/stroke with a CCE identified on CT between deceber 2019 and april 2023.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with CEE treated with intravenous thrombolysis (IVT) between 2015 and 2020 managed at the CHU de Nîmes or Patients with TIA/stroke with ECC identified on CT between 12/2019 and 04/2023 managed at CHU de Nîmes\n\nExclusion Criteria:\n\n* Patient's refusal to use his/her data"}, 'identificationModule': {'nctId': 'NCT06309069', 'acronym': 'CCE Cohorte', 'briefTitle': 'Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort', 'orgStudyIdInfo': {'id': 'LOCAL/2024/TP-01'}, 'secondaryIdInfos': [{'id': 'IRB 24.01.01', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with CCE', 'description': 'CCE patients identified between 2015 and 2023', 'interventionNames': ['Other: None, purely observational study']}], 'interventions': [{'name': 'None, purely observational study', 'type': 'OTHER', 'description': 'None, purely observational study', 'armGroupLabels': ['Patients with CCE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Anissa MEGZARI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nīmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}