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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Neurosurgical Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Science and Technology of the People's Repubic of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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