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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03153878
Other study ID # 2016YFC1300803
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 11, 2017
Last updated May 11, 2017
Start date June 1, 2017
Est. completion date December 31, 2021

Study information

Verified date May 2017
Source West China Hospital
Contact Zhiyong Liu, M.D, Ph.D
Phone +8613658021726
Email doctor_lzy@163.com
Is FDA regulated No
Health authority
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 benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. 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 benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. 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 Not yet recruiting
Enrollment 1800
Est. completion date December 31, 2021
Est. primary completion date December 31, 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 14years;

4. Patient consenting to participate to the study;

5. Patients with a definite history of ischemic heart disease or ischemic stroke who accept antithrombotic or anticoagulant therapy for secondary pevention

Exclusion Criteria:

Subarachnoid hemorrhage with unknown causes;

- Page 4 of 4 [DRAFT] - 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 Design


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Liu Zhiyong Xuanwu Hospital, Beijing

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 Aneurysm rupture Up to 4 years or time of aneurysm repair surgery
Primary Morphological changes of aneurysms maximum diameter increase = 1mm or appearance of a daughter sac Up to 4 years or time of aneurysm repair surgery
Secondary Acute myocardial infarction Acute myocardial infarction Up to 4 years]
Secondary New onset ischemic stroke New onset ischemic stroke Up to 4 years]
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