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Intracranial AneurysmCIAP-2NCT03133624

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

An observational study of Intracranial Aneurysm, run by Beijing Neurosurgical Institute at 12 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 14 years and older
Conditions the study is for
Intracranial Aneurysm
How many people
500 participants
Where
12 sitesChina
Study dates
1 May 2017to 31 Dec 2021
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

Jian Liu, MD contact

+86-010-67098852

jianliu_ns@163.com

Junfan Chen, MS contact

+86-010-67098852

junfan-chen@foxmail.com

12 sites in 1 country

China12 sites, 12 recruiting

  • XuanWu Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100053

    Peng Hu, MD, +86-13811385341, doctor_hupeng@163.com

    Hongqi Zhang, MD

    Not yet recruiting

  • Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University

    Beijing, 100050

    Xinjian Yang, MD, +86-010-67098852, yangxinjian@bjttyy.org

    Jian Liu, MD, +86-010-67098852, jianliu_ns@163.com

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Mingming Zhang, MD, +86-13907483144, zmm-zh@163.com

    Yugang Jiang, MD

    Not yet recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Zhiyong Liu, MD, +86-13658021726, doctor_lzy@163.com

    Min He, MD

    Not yet recruiting

  • The 1st Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Zongduo Guo, MD, +86-13594118695, stonegzd@163.com

    Xiaochuan Sun, MD

    Not yet recruiting

  • Southern Medical University, Zhujiang Hospital

    Guangzhou, Guangdong, 510282

    Xin Zhang, MD, +86-15989058895, zhangxin19830818@163.com

    Chuanzhi Duan, MD

    Not yet recruiting

  • Liao Cheng People's Hospital

    Liaocheng, Shandong, 252004

    Qingke Cui, MS, +86-1378718865, 45587746@qq.com

    Jiyue Wang, MS

    Not yet recruiting

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

    Shenghao Ding, MD, +86-13817282259, ding_sheng_hao@126.com

    Jieqing Wan, MD

    Not yet recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Wanchun You, MD, +86-18550038323, wcyou@suda.edu.cn

    Zhong Wang, MD

    Not yet recruiting

  • The First Affiliated Hospital Of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Kahriman Kadeer, MS, +86-18599088599, KAHriman@vip.qq.com

    Maimaitili Aisha, MS

    Not yet recruiting

  • Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China

    Xi’an, Shanxi, 710038

    Wei Guo, MD, +86-18729985168, 18729985168@163.com

    Yan Qu, MD

    Not yet recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361000

    Junlong Kang, MS, +86-15960256931, kjl295@163.com

    Xinhua Tian, MD

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

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
Medical subject headings
Intracranial Aneurysm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rupture of intracranial aneurysms

    The rupture of unruptured intracranial aneurysms.

    Measured: Up to 12 months or time of aneurysm repair surgery

Secondary outcomes (1)

  1. Changes in morphology of unruptured intracranial aneurysms

    Maximum diameter increase ≥ 1mm or appearance of a daughter sac.

    Measured: Up to 12 months or time of aneurysm repair surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study start1 May 2017
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03133624
Sponsor's protocol ID
2016YFC1300802
Acronym
CIAP-2
Status last verified
Aug 2018
First submitted
16 Apr 2017
Last updated
10 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: we can share the original data 5 years after the study.

Publications

  • 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.

    PubMed 9867550

  • 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.

    PubMed 22738097

  • 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.

    PubMed 26089327

  • 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.

    PubMed 24220206

  • 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.

    PubMed 24126645

  • Fan XX, Geng JW, He C, Hu P, Sun LY, Zhang HQ. Analysis of the wall thickness of intracranial aneurysms: Can computational fluid dynamics detect the translucent areas of saccular intracranial aneurysms and predict the rupture risk preoperatively? Front Neurol. 2023 Jan 9;13:1075078. doi: 10.3389/fneur.2022.1075078. eCollection 2022.

    PubMed 36698880

  • 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.

    PubMed 30257699

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Beijing Neurosurgical Institute at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jian Liu, MD (+86-010-67098852, jianliu_ns@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rupture of intracranial aneurysms (time frame: Up to 12 months or time of aneurysm repair surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03133624, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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CIAP-2 Clinical Trial NCT03133624 | AzTrials