A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms

Intracranial Aneurysm Clinical Trial

— CIAP-2  

Official title:

This is a Registry Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03133624
• Other study ID #: 2016YFC1300802
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2018
• Source: Beijing Neurosurgical Institute
• Contact: Jian Liu, MD
• Phone: +86-010-67098852
• Email: jianliu_ns[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Rupture

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University	Beijing
China	XuanWu Hospital,Capital Medical University	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The 1st Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Southern Medical University, Zhujiang Hospital	Guangzhou	Guangdong
China	Liao Cheng People's Hospital	Liaocheng	Shandong
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First Affiliated Hospital Of Xinjiang Medical University	Wulumuqi	Xinjiang
China	Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China	Xi'an	Shanxi
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute	Ministry of Science and Technology of the People's Repubic of China

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Erratum in: N Engl J Med 1999 Mar 4;340(9):744. — View 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 — View 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. — View 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 Cardiovascul — View 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):2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rupture of intracranial aneurysms	The rupture of unruptured intracranial aneurysms.	Up to 12 months or time of aneurysm repair surgery
Secondary	Changes in morphology of unruptured intracranial aneurysms	Maximum diameter increase = 1mm or appearance of a daughter sac.	Up to 12 months or time of aneurysm repair surgery