Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT04043559
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2019-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Cerebellar Infarctions Associated With Patent Foramen Ovale in Young Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020520', 'term': 'Brain Infarction'}], 'ancestors': [{'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': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2019-08-01', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of infarction lesions', 'timeFrame': 'day 1', 'description': 'Number (increase)'}, {'measure': 'infarction location', 'timeFrame': 'day 1', 'description': 'anterior, posterior, or mixed anterior-posterior circulation and the cortical/subcortical/corticosubcortical location of infarction'}, {'measure': 'size of subcortical lesion', 'timeFrame': 'day 1', 'description': '\\< or \\>15mm'}, {'measure': 'presence of multiterritorial infarction', 'timeFrame': 'day 1', 'description': 'mixed anterior-posterior circulation or bilateral anterior circulation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Infarction']}, 'referencesModule': {'references': [{'pmid': '32062661', 'type': 'RESULT', 'citation': 'Renard D, Ion I, Ricci JE, Mura T, Thouvenot E, Wacongne A. Chronic Small Cortical Cerebellar Infarctions on MRI are Associated with Patent Foramen Ovale in Young Cryptogenic Stroke. Cerebrovasc Dis. 2020;49(1):105-109. doi: 10.1159/000505959. Epub 2020 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The investigator retrospectively analyzed consecutive young (\\<60 years) cryptogenic stroke patients with Patient Foramen Ovale (PFO) recruited between January 2016 and May 2019 in our center, and compared these patients with sex- and age-matched controls with cryptogenic stroke without PFO. Analyzed baseline characteristics: sex, age, cardiovascular risk factors, history of stroke, and cortical/subcortical localization, arterial territory, number of lesions, and lesion size of the acute symptomatic infarction, together with the ROPE score. The presence and the number of acute and chronic SCCI lesions were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive young (\\<60 years) cryptogenic stroke patients with PFO recruited between January 2016 and May 2019 in our center, and compared these patients with sex- and age-matched controls with cryptogenic stroke without PFO.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients : young (\\<60 years) adult patients,\n* Patient recruited and registered in our stroke database between January 2016 and May 2016 of our center (Nîmes University Hospital, France),\n* Patients presenting with an acute symptomatic infarction (confirmed by diffusion-weighted MRI) of unknown origin\n* Controls : age-matched controls with cryptogenic stroke without PFO'}, 'identificationModule': {'nctId': 'NCT04043559', 'briefTitle': 'Cortical Cerebellar Infarctions Associated With Patent Foramen Ovale in Young Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Small Cortical Cerebellar Infarctions Are Associated With Patent Foramen Ovale in Young Cryptogenic Stroke Patients', 'orgStudyIdInfo': {'id': 'Local/2019/DR-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with an acute symptomatic infarction', 'interventionNames': ['Other: MRI scanner', 'Other: Contrast transoesophageal echocardiography']}, {'label': 'controls with cryptogenic stroke', 'interventionNames': ['Other: MRI scanner', 'Other: Contrast transoesophageal echocardiography']}], 'interventions': [{'name': 'MRI scanner', 'type': 'OTHER', 'description': 'MRI was performed with a 1.5T magnet (Ingenia, Philips, The Netherlands; diffusion-weighted imaging b-values = 0 and 1,000 s/mm2, TR 4,280 ms, and TE 97 ms). In case of technical problems with the 1.5T MRI scanner, a 3T magnet (Skyra, Siemens, Erlangen, Germany) was used. MRI was analyzed by an experienced rater (DR), blinded to clinical data and MRI sequences other than diffusion-weighted imaging.', 'armGroupLabels': ['controls with cryptogenic stroke', 'patients with an acute symptomatic infarction']}, {'name': 'Contrast transoesophageal echocardiography', 'type': 'OTHER', 'description': 'Contrast transoesophageal echocardiography (including Valsalva manoeuvre)', 'armGroupLabels': ['controls with cryptogenic stroke', 'patients with an acute symptomatic infarction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}