The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.

Study Overview

• Status: Unknown
• Conditions: Aneurysm, Intracranial; Natural History

Detailed Description

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the risk factors for the rupture of the UIA and their joint effect. The investigators aim to use research data to create a China national database of UIA.

This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China. During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year.

Research data will represent the real natural course of UIA in China.

For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tandu Hospital, Fourth Military Medical University
      • Contact: Haixiao Liu, M.D; Phone Number: 86-15929315407; Email: 56761311@qq.com
      • Contact: Wei Guo, M.D Ph.D; Phone Number: 86-18729985168; Email: 18729985168@163.com
      • Principal Investigator: Yan Qu, M.D, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients who diagnosed as unruptured intracranial aneurysms

Description

Inclusion Criteria:

1. Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA)
2. Patient with premorbid mRS of 3 or less.
3. Patient older than 18 years
4. Patient consenting to participate to the study

Exclusion Criteria:

1. Subarachnoid hemorrhage with unknown causes
2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas
3. Patient with malignant tumor
4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related.
5. Inability to obtain informed consent.
6. Patients with a life expectancy less than 1 year
7. Participating in the other clinical studies of intracranial aneurysm
8. Refusal of follow-up

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
aneurysm rupture rate	aneurysm rupture rate	Up to 4 years or time of aneurysm repair surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphological changes of aneurysms	maximum diameter increase ≥ 1mm or appearance of a daughter sac	Up to 4 years or time of aneurysm repair surgery

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Collaborators: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Yan Qu, M.D, Ph.D, Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China

Publications and helpful links

General Publications

• Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
• 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. Erratum In: N Engl J Med 1999 Mar 4;340(9):744.
• 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.
• Liu H, Guo W, Xiang S, Hu P, Sun F, Gao J, Zhang X, Wang P, Jing W, Zhang L, Yang X, Duan C, He M, Zhang H, Qu Y. The natural course of unruptured intracranial aneurysms in a Chinese cohort: protocol of a multi-center registration study in CIAP. J Transl Med. 2019 Oct 22;17(1):349. doi: 10.1186/s12967-019-2092-z.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 2, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Multicenter Studies; Registries; People's Republic of China; Aneurysm, Intracranial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 2016YFC1300801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: share the original data 5 years after the study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No