Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 7:36 AM
Study NCT ID:
NCT04253535
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of CAD during pregnancy, childbirth or puerperium', 'timeFrame': 'Day 0', 'description': 'This primary study endpoint will be evaluated by a questionnaire asked directly to participating women.'}], 'secondaryOutcomes': [{'measure': 'To determine the absolute risk of recurrence of CAD in this population.', 'timeFrame': 'Day 0', 'description': 'This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.'}, {'measure': 'To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.', 'timeFrame': 'Day 0', 'description': 'This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.'}, {'measure': 'To study the reasons of absence of pregnancy after a history of CAD', 'timeFrame': 'Day 0', 'description': 'This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Puerperium Recurrence', 'Cervical artery dissection'], 'conditions': ['Cervical Artery Dissection']}, 'descriptionModule': {'briefSummary': 'Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.', 'detailedDescription': 'In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text search with key words ("cervical or carotid or vertebral dissection") has been created in a data warehouse of the University Hospital of Nantes.\n\nTo determine the recurrence of CAD during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be conducted by the same investigator, an experienced neurologist. Information about recurrence of CAD, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. In case of no further pregnancy after the dissection, the reason will be explored.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* Extracranial carotid or vertebral dissection\n* Symptomatic dissection (with symptom onset within the last four weeks)\n* Spontaneous dissection\n* Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Extracranial carotid or vertebral dissection\n* Symptomatic dissection (with symptom onset within the last four weeks)\n* Spontaneous dissection\n* Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.\n\nExclusion Criteria:\n\n* Minors or adults under guardianship\n* Intracranial artery dissection\n* Traumatic or iatrogenic dissection\n* Patient refusal to participate'}, 'identificationModule': {'nctId': 'NCT04253535', 'briefTitle': 'Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies', 'orgStudyIdInfo': {'id': 'RC19_0267'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaries', 'type': 'OTHER', 'description': 'Study on questionnaries'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}