A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms (CIAP-2)

August 8, 2018 updated by: Xinjian Yang, MD, Beijing Neurosurgical Institute

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

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • Recruiting
        • Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University
        • Contact:
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100053
        • Not yet recruiting
        • Xuanwu Hospital，Capital Medical University
        • Contact:
        • Principal Investigator:
          • Hongqi Zhang, MD
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Not yet recruiting
        • The 1st Affiliated Hospital of Chongqing Medical University
        • Contact:
        • Principal Investigator:
          • Xiaochuan Sun, MD
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Not yet recruiting
        • Zhongshan Hospital Xiamen University
        • Contact:
          • Junlong Kang, MS
          • Phone Number: +86-15960256931
          • Email: kjl295@163.com
        • Principal Investigator:
          • Xinhua Tian, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Not yet recruiting
        • Southern medical university, zhujiang hospital
        • Contact:
        • Principal Investigator:
          • Chuanzhi Duan, MD
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Mingming Zhang, MD
          • Phone Number: +86-13907483144
          • Email: zmm-zh@163.com
        • Principal Investigator:
          • Yugang Jiang, MD
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Not yet recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
        • Principal Investigator:
          • Zhong Wang, MD
    • Shandong
      • Liaocheng, Shandong, China, 252004
        • Not yet recruiting
        • Liao Cheng People's Hospital
        • Contact:
        • Principal Investigator:
          • Jiyue Wang, MS
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Not yet recruiting
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jieqing Wan, MD
    • Shanxi
      • Xi'an, Shanxi, China, 710038
        • Not yet recruiting
        • Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China
        • Contact:
        • Principal Investigator:
          • Yan Qu, MD
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Principal Investigator:
          • Min He, MD
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830000
        • Not yet recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Maimaitili Aisha, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rupture of intracranial aneurysms
Time Frame: Up to 12 months or time of aneurysm repair surgery
The rupture of unruptured intracranial aneurysms.
Up to 12 months or time of aneurysm repair surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in morphology of unruptured intracranial aneurysms
Time Frame: Up to 12 months or time of aneurysm repair surgery
Maximum diameter increase ≥ 1mm or appearance of a daughter sac.
Up to 12 months or time of aneurysm repair surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Collaborators

Ministry of Science and Technology of the People's Repubic of China

Investigators

  • Principal Investigator: Xinjian Yang, MD, Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University，China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 16, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC1300802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

we can share the original data 5 years after the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intracranial Aneurysm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe