Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-04 @ 6:13 AM
Study NCT ID:
NCT03117803
Status:
UNKNOWN
Last Update Posted:
2017-07-05
First Post:
2017-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-02', 'studyFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aneurysm rupture rate', 'timeFrame': 'Up to 4 years or time of aneurysm repair surgery', 'description': 'aneurysm rupture rate'}], 'secondaryOutcomes': [{'measure': 'Morphological changes of aneurysms', 'timeFrame': 'Up to 4 years or time of aneurysm repair surgery', 'description': 'maximum diameter increase ≥ 1mm or appearance of a daughter sac'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aneurysm, Intracranial', 'Registries', 'Multicenter Studies', "People's Republic of China"], 'conditions': ['Aneurysm, Intracranial', 'Natural History']}, 'referencesModule': {'references': [{'pmid': '9867550', 'type': 'BACKGROUND', 'citation': 'International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.'}, {'pmid': '12867109', 'type': 'BACKGROUND', 'citation': "Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3."}, {'pmid': '22738097', 'type': 'BACKGROUND', 'citation': 'UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.'}, {'pmid': '31640726', 'type': 'DERIVED', 'citation': 'Liu H, Guo W, Xiang S, Hu P, Sun F, Gao J, Zhang X, Wang P, Jing W, Zhang L, Yang X, Duan C, He M, Zhang H, Qu Y. The natural course of unruptured intracranial aneurysms in a Chinese cohort: protocol of a multi-center registration study in CIAP. J Transl Med. 2019 Oct 22;17(1):349. doi: 10.1186/s12967-019-2092-z.'}]}, 'descriptionModule': {'briefSummary': 'This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.', 'detailedDescription': "This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.\n\nThis study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China. During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year.\n\nResearch data will represent the real natural course of UIA in China.\n\nFor this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who diagnosed as unruptured intracranial aneurysms', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA)\n2. Patient with premorbid mRS of 3 or less.\n3. Patient older than 18 years\n4. Patient consenting to participate to the study\n\nExclusion Criteria:\n\n1. Subarachnoid hemorrhage with unknown causes\n2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas\n3. Patient with malignant tumor\n4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related.\n5. Inability to obtain informed consent.\n6. Patients with a life expectancy less than 1 year\n7. Participating in the other clinical studies of intracranial aneurysm\n8. Refusal of follow-up'}, 'identificationModule': {'nctId': 'NCT03117803', 'briefTitle': 'The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort', 'orgStudyIdInfo': {'id': '2016YFC1300801'}}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Guo, M.D Ph.D', 'role': 'CONTACT', 'email': '18729985168@163.com', 'phone': '86-18729985168'}, {'name': 'Haixiao Liu, M.D', 'role': 'CONTACT', 'email': '56761311@qq.com', 'phone': '86-15929315407'}, {'name': 'Yan Qu, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tandu Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Wei Guo, M.D, Ph.D', 'role': 'CONTACT', 'email': '18729985168@163.com', 'phone': '86-18729985168'}, {'name': 'Haixiao Liu, M.D', 'role': 'CONTACT', 'email': '56761311@qq.com', 'phone': '86-15929315407'}], 'overallOfficials': [{'name': 'Yan Qu, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'share the original data 5 years after the study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}