Clinical trial NCT03133624: A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms
Official title: This is a Registry Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Keywords: unruptured intracranial aneurysms
rupture risk
computational fluid dynamic
high resolution magnetic resonance images
gene
multi dimensional prediction model
clinical features
risk factors
registry study
china
biomarkers
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2017-04-28
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with at least 1 UIA that is untreated and confirmed by imaging (CTA, MRA and DSA), regardless of the presence of clinical symptoms.

Brief summary: This is a registry study on a multidimensional prediction model for rupture risk of unruptured intracranial aneurysms in China.

Detailed description: This subsequent program China Intracranial Aneurysm Project - 2 (CIAP-2) will comprise screening of 500 patients from the UIA cohort (CIAP-1) and focus on hemodynamics factors, high resolution magnetic resonance imaging (HRMRI), genetic factors and biomarkers. Possible risk factors for rupture of UIA, including genetic factors, biomarkers, HRMRI, and hemodynamic will be analyzed. The first project of the China Intracranial Aneurysm Project (CIAP-1: Chaired by the Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China) will establish a prospective cohort of 5000 patients with UIA from 20 centers in China, and collect baseline information for each patient. Multidimensional data will be acquired in follow-up assessments. Statistically significant clinical features in the UIA cohort will also be analyzed and integrated into this model for predicting risk of UIA rupture. After the model has been set up, the resultant evidence-based prediction will be used to provide a preliminary theoretical basis for the treatment of aneurysms at high risk of rupture.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

* 0 Completely silent
* 1 Despite symptoms, but not visibly disabled, can complete all regular duties and activities
* 2 Mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance
* 3 Moderate disability requires some help, but walking does not need assistance;
* 4 Severe disabilities, unable to walk independently, no others can not meet their needs
* 5 Severely disabled, bedridden, Urine, requiring continuous care and care;
* 6 Mortality

Primary outcomes:
measure: The rupture of intracranial aneurysms
timeFrame: Up to 12 months or time of aneurysm repair surgery
Secondary outcomes:
measure: Changes in morphology of unruptured intracranial aneurysms
timeFrame: Up to 12 months or time of aneurysm repair surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: XuanWu Hospital,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The 1st Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University, Zhujiang Hospital
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Liaocheng
country: China
facility: Liao Cheng People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Wulumuqi
country: China
facility: The First Affiliated Hospital Of Xinjiang Medical University
state: Xinjiang
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
Study officials:
affiliation: Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University，China
name: Xinjian Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Thompson 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.
citation: Liu 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.
citation: Li 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.
citation: Chen 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.