China Intracranial Aneurysm Project (CIAP): protocol for a registry study on a multidimensional prediction model for rupture risk of unruptured intracranial aneurysms

Junfan Chen; Jian Liu; Yisen Zhang; Zhongbin Tian; Kun Wang; Ying Zhang; Shiqing Mu; Ming Lv; Peng Jiang; ChuanZhi Duan; Hongqi Zhang; Yan Qu; Min He; Xinjian Yang

doi:10.1186/s12967-018-1641-1

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.

Authors

Junfan Chen¹, Jian Liu¹, Yisen Zhang¹, Zhongbin Tian¹, Kun Wang¹, Ying Zhang¹, Shiqing Mu¹, Ming Lv¹, Peng Jiang¹, ChuanZhi Duan², Hongqi Zhang³, Yan Qu⁴, Min He⁵, Xinjian Yang⁶

Affiliations

¹ Department of Interventional Neuroradiology, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, China.
² Department of Neurosurgery, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.
³ Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
⁴ Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shanxi, China.
⁵ Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
⁶ Department of Interventional Neuroradiology, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, China. yangxinjian@voiceoftiantan.org.

Abstract

Background: Ruptured aneurysms, the commonest cause of nontraumatic subarachnoid hemorrhage, can be catastrophic; the mortality and morbidity of affected patients being very high. Some risk factors, such as smoking, hypertension and female sex have been identified, whereas others, such as hemodynamics, imaging, and genomics, remain unclear. Currently, no accurate model that includes all factors for predicting such rupture is available. We plan to use data from a large cohort of Chinese individuals to set up a multidimensional model for predicting risk of rupture of unruptured intracranial aneurysms (UIAs).

Methods: The China Intracranial Aneurysm Project-2 (CIAP-2) will comprise screening of a cohort of 500 patients with UIA (From CIAP-1) and focus on hemodynamic factors, high resolution magnetic resonance imaging (HRMRI) findings, genetic factors, and biomarkers. Possible risk factors for rupture of UIA, including genetic factors, biomarkers, HRMRI, and hemodynamic factors, 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 prospectively collect a 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 the model for predicting risk of UIA rupture. After the model has been set up, the resultant evidence-based prediction will provide a preliminary theoretical basis for treating aneurysms at high risk of rupture.

Discussion: This study will explore the risk of rupture of aneurysms and develop a scientific multidimensional model for predicting rupture of unruptured intracranial aneurysms. Clinical Trials registration A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms (CIAP-2), NCT03133624. Registered: 16 April 2017. https://clinicaltrials.gov/ct2/show/NCT03133624.

Keywords: Hemodynamics; Prospective study; Rupture risk; Un-ruptured aneurysms.

Publication types

Clinical Trial
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aneurysm, Ruptured / pathology*
China
Humans
Intracranial Aneurysm / pathology*
Models, Biological*
Registries*
Risk Factors

Associated data

ClinicalTrials.gov/NCT03133624