The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort

Aneurysm, Intracranial Clinical Trial

Official title:

The Natural Course of Unruptured Intracranial Aneurysms in a Chinese Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03117803
• Other study ID #: 2016YFC1300801
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2017
• Last updated: July 2, 2017
• Start date: May 1, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2017
• Source: Tang-Du Hospital
• Contact: Wei Guo, M.D, Ph.D
• Phone: 86-18729985168
• Email: 18729985168[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Intracranial
• Intracranial Aneurysm
• Natural History

Locations

Country	Name	City	State
China	Tandu Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Tang-Du Hospital	Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (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. Erratum in: N Engl J Med 1999 Mar 4;340(9):744. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aneurysm rupture rate	aneurysm rupture rate	Up to 4 years or time of aneurysm repair surgery
Secondary	Morphological changes of aneurysms	maximum diameter increase = 1mm or appearance of a daughter sac	Up to 4 years or time of aneurysm repair surgery