Screening Intracranial Aneurysms With Magnetic Resonance Angiography (MRA) in China
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition |
|---|
|
Intracranial Aneurysm |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | Epidemiology of Cerebral Aneurysms With MRA in China in Middle-aged or Elder Person: a Population-based Survey |
- Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T [ Time Frame: 18 months after the study ] [ Designated as safety issue: Yes ]
- Suspected cerebral aneurysms detected by MRA underwent digital subtraction angiography (DSA) examination [ Time Frame: 32-36 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 4500 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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.
Contacts and Locations| Contact: Yong-Dong Li, MD, PhD | 0086-21-64844183 | dr_liyongdong@sina.com.cn |
| Contact: Ming-Hua Li, MD, PhD | 0086-21-64844183 | liminhua@online.sh.cn |
| China, Shanghai | |
| The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University | Recruiting |
| Shanghai, Shanghai, China, 200233 | |
| Contact: Yong-Dong Li, MD, Ph.D 0086-21-64844183 dr_liyongdong@sina.com.cn | |
| Contact: Ming-Hua Li, MD, Ph.D 0086-21-64844183 liminhua@online.sh.cn | |
| Principal Investigator: Ming-Hua Li, MD, PhD | |
| Principal Investigator: Yong-Dong Li, MD, PhD | |
| Principal Investigator: Shi-Wen Chen, MD, PhD | |
| Sub-Investigator: Yuan-Chang Chen, MD, PhD | |
| Sub-Investigator: Hua-Qiao Tan, MD, PhD | |
| Sub-Investigator: Chun Fang, MD | |
| Sub-Investigator: Ding-Jun Hu, MD | |
| Sub-Investigator: Jia-Yin Zhang, MD | |
| Sub-Investigator: Qian Wu, MD | |
| Sub-Investigator: Rui-Hua Qiao, MS | |
| Sub-Investigator: Wei-Ping Jia, MD, PhD | |
| Sub-Investigator: Wen-Hong Zong, MD | |
| Sub-Investigator: Yin Zhang, MD | |
| Sub-Investigator: Wei Lou, MD | |
| Sub-Investigator: Wei-Zhen Shen, MD | |
| Sub-Investigator: Sui-Xin Ding, MD | |
| Sub-Investigator: Wang Wu, MD | |
| Sub-Investigator: Bei-Lei Zhang, MD | |
| Sub-Investigator: Yue-Qi Zhu, MD | |
| 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 |
More Information
Publications:
| Responsible Party: | Cerebral aneurysm study in China, The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University |
| ClinicalTrials.gov Identifier: | NCT00926172 History of Changes |
| Other Study ID Numbers: | CASC1, SAPH001 |
| Study First Received: | June 19, 2009 |
| Last Updated: | December 11, 2009 |
| Health Authority: | China: National Natural Science Foundation |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
Magnetic resonance angiography Intracranial aneurysm cerebral aneurysm |
unruptured aneurysm Epidemiology Magnetic Resonance Imaging |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013