Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
Recruitment status was Recruiting
To monitor and evaluate the change of intracranial hemodynamics and MCA stenosis after 24-week atorvastatin treatment using CEUS, CTA and DSA.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis After 24-week Atorvastatin Treatment|
- Hemodynamics changes and MCA stenosis [ Time Frame: given atorvastatin 40mg treatment for 24 weeks ] [ Designated as safety issue: No ]Hemodynamics changes will be evaluaed using CEUS at baseline, 3-month,and 6-month.in order to evaluate the effect of atorvastatin, we will compare the baseline with 3-month,and compare the baseline with 6-month.a statistic analysis of measure data is conducted by the group T test,which conducted by SAS 9.13 English edition .
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
30 patients who had MCA infarction within 6 months prior to screening, and has not received any statins treatment before stroke.in this study ,we will give them atorvastatin 40mg treatment for 24 weeks and monitor and evaluate the change of intracranial hemodynamics after treatment.
40mg per day,duration for 24 weeks
Other Name: brand names :FIZER
No Intervention: compare
30 patients who had MCA infarction within 6 months prior to screening, and has not received any statins treatment.we will monitor and evaluate the intracranial hemodynamics as a baseline.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617538
|Contact: Xu Bin, firstname.lastname@example.org|
|Contact: Zheng Shanshan, email@example.com|
|FuXing Hospital,Capital Medicial University||Recruiting|
|Beijing, China, 100038|
|Contact: Xu Bin, master 86-010-88062285 firstname.lastname@example.org|
|Principal Investigator: Xu Bin, master|
|Study Director:||Zhong Qin, master||science study Dept|