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

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ClinicalTrials.gov Identifier: NCT00926172
Recruitment Status : Unknown
Verified December 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : June 23, 2009
Last Update Posted : December 14, 2009
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine

June 19, 2009
June 23, 2009
December 14, 2009
June 2007
December 2008   (Final data collection date for primary outcome measure)
Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T [ Time Frame: 18 months after the study ]
Same as current
Complete list of historical versions of study NCT00926172 on ClinicalTrials.gov Archive Site
Suspected cerebral aneurysms detected by MRA underwent digital subtraction angiography (DSA) examination [ Time Frame: 32-36 months ]
Same as current
Not Provided
Not Provided
 
Screening Intracranial Aneurysms With Magnetic Resonance Angiography (MRA) in China
Epidemiology of Cerebral Aneurysms With MRA in China in Middle-aged or Elder Person: a Population-based Survey
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).

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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The investigators recruited 4500-5000 native inhabitants aged 35-75 years lived in China according to China census-tract data from the year 2005. The gender was accordance with China census-tract data, and the population aged 35-75 years has a higher incident of intracranial aneurysm in the literature. Assuming an 8 percent prevalence of intracranial aneurysm in the general population and using a two-sided alpha value of 0.05, the investigators estimated that 4500-5000 native inhabitants would need to be enrolled for the study.
Intracranial Aneurysm
Not Provided
Not Provided
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):3127-9. doi: 10.1161/STROKEAHA.109.553800. Epub 2009 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
4500
Same as current
June 2010
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00926172
CASC1
SAPH001
Yes
Not Provided
Not Provided
Cerebral aneurysm study in China, The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai Jiao Tong University School of Medicine
Not Provided
Study Chair: Ming-Hua Li, MD, PhD The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Principal Investigator: Yong-Dong Li, MD, PhD The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai Jiao Tong University School of Medicine
December 2009