Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT03418766
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2018-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Patients With Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'contrast-enhanced transcranial Doppler (c-TCD)', 'timeFrame': '1 year', 'description': 'Brain MRI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Right-to-left Shunt', 'Brain White Matter Lesions', 'Migraine'], 'conditions': ['White Matter Disease', 'Right-to-left Shunt', 'Migraine Disorders']}, 'referencesModule': {'references': [{'pmid': '18294247', 'type': 'RESULT', 'citation': 'Del Sette M, Dinia L, Bonzano L, Roccatagliata L, Finocchi C, Parodi RC, Sivori G, Gandolfo C. White matter lesions in migraine and right-to-left shunt: a conventional and diffusion MRI study. Cephalalgia. 2008 Apr;28(4):376-82. doi: 10.1111/j.1468-2982.2008.01544.x. Epub 2008 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the prevalence of white matter lesions in Chinese migraineurs with and without right-to-left shunt. The aim is to study the relationship among right-to-left shunt, migraine and white matter lesions.', 'detailedDescription': 'This is a prospective multicenter study of Chinese population. Participants (normal individuals without migraine and migraineurs) are included after standardized diagnostic procedures (TCD and migraine diagnosis). For all the participants, brain MRI and c-TCD are required. Up to 10-15 study sites nationwide will be needed to recruit the planned participant population during a 1-year period.\n\nThe information of each participants will be registered, including basic facts, the longitudinal headache history, frequency, location, quality, intensity, duration, accompanied symptoms, precipitating and exacerbating factors, with or without aura, and Headache Impact Test-6 (HIT-6) questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We detect RLS through contrast-enhanced transcranial Doppler (c-TCD). The normal individuals will be selected to group 1, while those who suffer from migraine will be selected to group 2. All the participants are required to take c-TCD and brain MRI.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who fulfilled the criteria for migraine according to the International Classification of Headache Disorders III-beta were included.\n\nhealthy volunteers without a history of migraine were included as controls.\n\nExclusion Criteria:\n\n* Subjects were excluded from the study if they had severe arterial stenosis, an insufficient temporal window, inadequate cubital venous access, and/or were unable to perform the Valsalva manoeuvre (VM) because of severe heart or lung disease.'}, 'identificationModule': {'nctId': 'NCT03418766', 'acronym': 'CAMBRAIN', 'briefTitle': 'The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Patients With Migraine', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'The Relationship Between Right-to-left Shunt and Brain White Matter Lesions in Chinese Patients With Migraine:a Multicenter Study. CAMBRAIN Study.', 'orgStudyIdInfo': {'id': 'CAMBRAIN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal', 'description': 'Normal healthy individual without migraine.'}, {'label': 'Magraine', 'description': 'Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingqi Xing, PhD', 'role': 'CONTACT'}, {'name': 'Yishui Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First hospital of Jilin Uni', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Yingqi Xing, MD,PhD', 'role': 'CONTACT', 'email': 'xingyq2009@sina.com', 'phone': '15844047846'}, {'name': 'Sibo Wang, MD,PhD', 'role': 'CONTACT', 'email': 'wangsibo92@163.com', 'phone': '15844008297'}], 'overallOfficials': [{'name': 'Yingqi Xing, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Sibo Wang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Yi Yang, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Yongsheng Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}