Screening Intracranial Aneurysms With Magnetic Resonance Angiography (MRA) in China

Intracranial Aneurysm Clinical Trial

Official title:

Epidemiology of Cerebral Aneurysms With MRA in China in Middle-aged or Elder Person: a Population-based Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00926172
• Other study ID #: CASC1
• Secondary ID: SAPH001
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2009
• Last updated: December 11, 2009
• Start date: June 2007
• Est. completion date: June 2010

Study information

• Verified date: December 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Yong-Dong Li, MD, PhD
• Phone: 0086-21-64844183
• Email: dr_liyongdong[@]sina.com.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

The Chinese Cerebral Aneurysms Survey is a continuing prospective study among middle-aged and older individuals (35 - 75 years) that aims to determine the prevalence of cerebral intracranial aneurysms in the general population with MRA at 3.0 Tesla (T).

Description:

Cerebral intracranial aneurysms are common. In angiographic and autopsy studies, estimates for prevalence vary between 0.2 and 9.9 percent. The methods used to detect the aneurysms markedly influenced the proportion of aneurysms. Retrospective autopsy studies probably give an underestimation and prospective angiography studies an overestimation of the actual prevalence. Accurate data on the prevalence of intracranial aneurysms are essential in evaluating the results of screening programs for aneurysms in general population.

During the past decade, MRA, as a preferred accuracy modality for noninvasive intracranial vascular imaging at most centers, is playing an increasing role in the evaluation of patients suspected of having intracranial aneurysms. In recurrent study, we have tested that MRA at 3T has excellent sensitivity, accuracy, and correlation with DSA and is comparable to catheter cerebral angiography for the evaluation of patients with intracranial aneurysms (Stroke, in press). Therefore, we examined trends in intracranial aneurysm prevalence with the use of MRA at 3.0T to determine the true prevalence of cerebral intracranial aneurysms in the general middle-aged or elder population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: June 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Native inhabitants lived in a defined area sites in China

• Aged 35-75 years

Exclusion Criteria:

• Less than 35 years old or more than 75 years old

• Incompetent patient who cannot give consent for routine MR Angiography and his/her surrogate decision maker is not available

• Any patients with a contraindication to having a standard MRI examination, such as phase maker, orbital metallic foreign body, etc.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
China	The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Li MH, Cheng YS, Li YD, Fang C, Chen SW, Wang W, Hu DJ, Xu HW. Large-cohort comparison between three-dimensional time-of-flight magnetic resonance and rotational digital subtraction angiographies in intracranial aneurysm detection. Stroke. 2009 Sep;40(9): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T		18 months after the study	Yes
Secondary	Suspected cerebral aneurysms detected by MRA underwent digital subtraction angiography (DSA) examination		32-36 months	Yes