A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms
CIAP-2
This is a Registry Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms in China
1 other identifier
observational
500
1 country
12
Brief Summary
This is a registry study on a multidimensional prediction model for rupture risk of unruptured intracranial aneurysms in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedAugust 10, 2018
August 1, 2018
3.7 years
April 16, 2017
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rupture of intracranial aneurysms
The rupture of unruptured intracranial aneurysms.
Up to 12 months or time of aneurysm repair surgery
Secondary Outcomes (1)
Changes in morphology of unruptured intracranial aneurysms
Up to 12 months or time of aneurysm repair surgery
Eligibility Criteria
Patients with at least 1 UIA that is untreated and confirmed by imaging (CTA, MRA and DSA), regardless of the presence of clinical symptoms.
You may qualify if:
- At least 1 UIA that is untreated and confirmed by imaging: Computed tomography angiography (CTA), magnetic resonance angiography (MRA) and digital subtraction angiography (DSA). Regardless of the presence of clinical symptoms
- Patient currently has the ability to live independently, and a modified Ranking Score less than or equal to 3 points
- Older than 14 years of age
- Patient or relatives agreed to sign the consent form
You may not qualify if:
- Subarachnoid hemorrhage of unknown origin
- Presence of other intracranial vascular malformations, such as cerebral arteriovenous malformation (AVM) or cerebral arteriovenous fistula (AVF)
- Intracranial and other malignant tumors
- Fusiform, traumatic, bacterial or dissecting aneurysm
- Patients with severe mental illness who are unable to communicate
- Patients with other diseases or poor general condition who are expected to survive less than 1 year
- Patients with intracranial aneurysms who have joined other similar research institutions
- Patients who refused follow-up
- The definition of modified Ranking Score:
- Completely silent
- Despite symptoms, but not visibly disabled, can complete all regular duties and activities
- Mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance
- Moderate disability requires some help, but walking does not need assistance;
- Severe disabilities, unable to walk independently, no others can not meet their needs
- Severely disabled, bedridden, Urine, requiring continuous care and care;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
XuanWu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053, China
The 1st Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361000, China
Southern Medical University, Zhujiang Hospital
Guangzhou, Guangdong, 510282, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Liao Cheng People's Hospital
Liaocheng, Shandong, 252004, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China
Xi’an, Shanxi, 710038, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital Of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, 100050, China
Related Publications (7)
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: 9867550RESULTUCAS 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: 22738097RESULTThompson BG, Brown RD Jr, Amin-Hanjani S, Broderick JP, Cockroft KM, Connolly ES Jr, Duckwiler GR, Harris CC, Howard VJ, Johnston SC, Meyers PM, Molyneux A, Ogilvy CS, Ringer AJ, Torner J; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention; American Heart Association; American Stroke Association. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Aug;46(8):2368-400. doi: 10.1161/STR.0000000000000070. Epub 2015 Jun 18.
PMID: 26089327RESULTLiu J, Xiang J, Zhang Y, Wang Y, Li H, Meng H, Yang X. Morphologic and hemodynamic analysis of paraclinoid aneurysms: ruptured versus unruptured. J Neurointerv Surg. 2014 Nov;6(9):658-63. doi: 10.1136/neurintsurg-2013-010946. Epub 2013 Nov 12.
PMID: 24220206RESULTLi MH, Chen SW, Li YD, Chen YC, Cheng YS, Hu DJ, Tan HQ, Wu Q, Wang W, Sun ZK, Wei XE, Zhang JY, Qiao RH, Zong WH, Zhang Y, Lou W, Chen ZY, Zhu Y, Peng DR, Ding SX, Xu XF, Hou XH, Jia WP. Prevalence of unruptured cerebral aneurysms in Chinese adults aged 35 to 75 years: a cross-sectional study. Ann Intern Med. 2013 Oct 15;159(8):514-21. doi: 10.7326/0003-4819-159-8-201310150-00004.
PMID: 24126645RESULTFan XX, Geng JW, He C, Hu P, Sun LY, Zhang HQ. Analysis of the wall thickness of intracranial aneurysms: Can computational fluid dynamics detect the translucent areas of saccular intracranial aneurysms and predict the rupture risk preoperatively? Front Neurol. 2023 Jan 9;13:1075078. doi: 10.3389/fneur.2022.1075078. eCollection 2022.
PMID: 36698880DERIVEDChen J, Liu J, Zhang Y, Tian Z, Wang K, Zhang Y, Mu S, Lv M, Jiang P, Duan C, Zhang H, Qu Y, He M, Yang X. China Intracranial Aneurysm Project (CIAP): protocol for a registry study on a multidimensional prediction model for rupture risk of unruptured intracranial aneurysms. J Transl Med. 2018 Sep 26;16(1):263. doi: 10.1186/s12967-018-1641-1.
PMID: 30257699DERIVED
Biospecimen
whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xinjian Yang, MD
Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University，China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair of Department of Interventional Neuroradiology of Beijing Neurosurgical Institute
Study Record Dates
First Submitted
April 16, 2017
First Posted
April 28, 2017
Study Start
May 1, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
August 10, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
we can share the original data 5 years after the study.