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

NCT ID: NCT01031147

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Intracranial Aneurysms

Keywords

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Magnetic resonance angiography Intracranial aneurysm Digital subtraction angiography Volume rendering

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Magnetic resonance angiography

Three-dimensional time-of-flight magnetic resonance angiography(3D-TOF-MRA) was used to detect the intracranial aneurysms in this study

Examination

Intervention Type OTHER

3D-TOF-MRA was performed for suspected patients to detect intracranial aneurysm, and subsequently underwent digital subtraction angiography

Interventions

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Examination

3D-TOF-MRA was performed for suspected patients to detect intracranial aneurysm, and subsequently underwent digital subtraction angiography

Intervention Type OTHER

Other Intervention Names

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3D-TOF-MRA

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University

Locations

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The Sixth Affiliated People's Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong-Dong Li, MD, Ph.D.

Role: CONTACT

Phone: 0086-21-64844183

Email: [email protected]

Minh-Hua Li, MD, Ph.D.

Role: CONTACT

Phone: 0086-21-64844183

Email: [email protected]

Facility Contacts

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Yong-Dong Li, MD, Ph.D.

Role: primary

Ming-Hua Li, MD, Ph.D.

Role: backup

References

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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.

Reference Type RESULT
PMID: 19556531 (View on PubMed)

Other Identifiers

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CASC3

Identifier Type: -

Identifier Source: org_study_id