Contrast-free Magnetic Resonance Angiography (MRA) at 3.0 T for Intracranial Aneurysm Detection
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Intracranial Aneurysms |
Other: Examination |
| Study Type: | Observational |
| Study Design: | 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) |
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 15 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| 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 |
| 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. | |
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 |
| Study First Received: | December 11, 2009 |
| Last Updated: | February 25, 2010 |
| Health Authority: | China: National Natural Science Foundation |
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 |
ClinicalTrials.gov processed this record on May 23, 2013