Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stenosis
Intervention: atorvastatin (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Capital Medical University Official(s) and/or principal investigator(s): Zhong Qin, master, Study Director, Affiliation: science study Dept
Overall contact: Xu Bin, master, Phone: 86-010-88062285, Email: xubincj1992@yahoo.com.cn
Summary
Objective:
To monitor and evaluate the change of intracranial hemodynamics and MCA stenosis after
24-week atorvastatin treatment using CEUS, CTA and DSA.
Study design:
Total 30 patients (60 arteries) will be enrolled in this study, who had MCA infarction
within 6 months prior to screening, and has not received any statins treatment before
stroke.
Eligible patient will receive atorvastatin 40mg treatment for 24 weeks. Hemodynamics changes
and MCA stenosis will be evaluated using CEUS at baseline, 3-month,and 6-month. MCA
stenosis, bloodstream velocity, as well as clinical symptoms will be assessed at each visit
and compared to baseline.
Clinical Details
Official title: Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis After 24-week Atorvastatin Treatment
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hemodynamics changes and MCA stenosis
Detailed description:
The cerebral infarction resulted from medially and heavily narrow MCA is determined by the
three-type screen method .For the first screen cerebral infarction patients of MCA area who
has the stroke or TIA history In 6 months are determined by the clinic stroke measure
table,transstadial Doppler ultrasonography (TCD) carotid ultrasonography and skull CT. For
the second the MAC area infarction and vessel narrow are determined by the skull magnetic
resonance (MRI) and magnetic resonance vessel imaging (MRA) and the MCA trend bloodstream
dynamics feature and narrow extent Are observed by the strengthened ultrasonography (CEVS)
For the third, The MCA narrow extent is measured by the DSA test which is currently regarded
as a gold standard and /or by the CTA .The atorvastatin 20mg Treatment is given to the
patients who all use the antiplatelet medicine The clinic symptom improvement MCA narrow
extent and bloodstream velocity are dynamically observed visited and analysed respectively
at the basic line 3 and 6 months after treatment
Eligibility
Minimum age: 40 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who had MCA infarction of unilateral with moderate to severe stenosis within
6 months prior to screening, and has not received any statins treatment before
stroke.
Exclusion Criteria:
- With side of extracranial carotid artery 70-100% severe narrow or block
- Vertebrobasilar artery lesions caused by cerebral infarction
- Have rheumatic heart disease, the atrial fibrillation of heart disease, those who
Cerebral hemorrhage patients
- Serious liver and kidney function is not complete patients.
Locations and Contacts
Xu Bin, master, Phone: 86-010-88062285, Email: xubincj1992@yahoo.com.cn
FuXing Hospital,Capital Medicial University, Beijing 100038, China; Recruiting Xu Bin, master, Phone: 86-010-88062285, Email: xubincj1992@yahoo.com.cn Xu Bin, master, Principal Investigator
Additional Information
Starting date: January 2012
Last updated: June 11, 2012
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