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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00926172
First received: June 19, 2009
Last updated: December 11, 2009
Last verified: December 2009
  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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Cerebral intracranial aneurysms identified by 3-D TOF-MRA at 3T [ Time Frame: 18 months after the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
Detailed 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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926172

Locations
China, Shanghai
The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200233
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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 December 07, 2016