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Contrast-free Magnetic Resonance Angiography (MRA) at 3.0 T for Intracranial Aneurysm Detection

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ClinicalTrials.gov Identifier: NCT01031147
Recruitment Status : Unknown
Verified December 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : December 14, 2009
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The Chinese Cerebral Aneurysms Survey is a continuing prospective study to evaluate the effectiveness of unenhanced, three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) with volume rendering (VR) at 3-T in the detection of intracranial aneurysms.

Condition or disease Intervention/treatment
Intracranial Aneurysms Other: Examination

Detailed Description:

Recent years,three-dimensional time-of-flight MRA (3D-TOF-MRA) has become a useful, contrast-free method for observing intracranial vessels and is widely utilized as a screening examination for intracranial aneurysms. The studies available in Medline show mixed results.Some of these studies just included MRI/MRA in the analysis, which have a high rate of false-positives and are unreliable, and some were lack of control (ruptured aneurysm), precise numbers of false-positive results, standard images process and review, or corroborative IADSA in some patients. Furthermore, most previous studies included small sample size with aneurysm detection at 0.5-T or 1.5-T MR. Thus, these results have been inconclusive because of certain pitfalls in these studies.

Since 2007, we have conducted a clinical study to objective detection of intracranial aneurysms in our routine diagnostic work-up of intracranial aneurysms by our neuroradiologists using a standard procedure with 3D-TOF-MRA with VR at 3T. The investigators want to establish the quality data to prospectively compare 3D-TOF-MRA with VR at 3T vs 3D-RDSA in the diagnosis of intracranial aneurysms in a largest cohort of patients and test it accuracy in screening for suspected patients


Study Design

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Intracranial Aneurysm With Non-enhanced, Three-dimensional Time-of-flight Magnetic Resonance Angiography(3D−TOF−MRA): a Prospective Comparison With Three-dimensional Reconstructed Digital Subtraction Angiography (3D RDSA)
Study Start Date : June 2007
Primary Completion Date : December 2008
Estimated Study Completion Date : December 2010

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Magnetic resonance angiography
Three-dimensional time-of-flight magnetic resonance angiography(3D−TOF−MRA) was used to detect the intracranial aneurysms in this study
Other: Examination
3D−TOF−MRA was performed for suspected patients to detect intracranial aneurysm, and subsequently underwent digital subtraction angiography
Other Name: 3D−TOF−MRA


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We estimated that a sample of 350 patients including 12% dropout rate would be enrolled to determine an accuracy of VR 3D-TOF-MRA versus VR RDSA as reference standard with a 95% confidence interval of 5% (i.e., a standard error of approximately 2.5 %) above and below the expected VR 3D-TOF-MRA accuracy of 95%. A P value of 0.05 was considered to indicate statistical significance.
Criteria

Inclusion Criteria:

  • Suspected or known intracranial aneurysms

Exclusion Criteria:

  • Patient's inability to cooperate
  • Chronic renal failure patients
  • Any patients with a contraindication to MRA examination, such as pacemaker, orbital metallic foreign body, coronary stent, etc.
  • Any patients with a contraindication to DSA examination, such as allergic to contrast medium, etc.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031147


Contacts
Contact: Yong-Dong Li, MD, Ph.D. 0086-21-64844183 dr_liyongdong@sina.com.cn
Contact: Minh-Hua Li, MD, Ph.D. 0086-21-64844183 liminhua@online.sh.cn

Locations
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, Ph.D.         
Principal Investigator: Yong-Dong Li, MD, Ph.D.         
Sub-Investigator: Hua-Qiao Tan, MD, Ph.D.         
Sub-Investigator: Shi-Wen Chen, MD, Ph.D.         
Sub-Investigator: Yuan-Chang Chen, MD.         
Sub-Investigator: Chun Fang, MD.         
Sub-Investigator: Jia-Ying Zhang, MD.         
Sub-Investigator: Ding-Jun Hu, MD.         
Sub-Investigator: Qing Wu, MD.         
Sub-Investigator: Wu Wang, MD.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
More Information

Publications:
Responsible Party: Cerebral aneurysm study in China, The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01031147     History of Changes
Other Study ID Numbers: CASC3
First Posted: December 14, 2009    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: December 2009

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Magnetic resonance angiography
Intracranial aneurysm
Digital subtraction angiography
Volume rendering

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