Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
|ClinicalTrials.gov Identifier: NCT01617538|
Recruitment Status : Unknown
Verified June 2012 by Bin Xu, MD, Capital Medical University.
Recruitment status was: Recruiting
First Posted : June 12, 2012
Last Update Posted : June 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Stenosis||Drug: atorvastatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis After 24-week Atorvastatin Treatment|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||September 2013|
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.
- Hemodynamics changes and MCA stenosis [ Time Frame: given atorvastatin 40mg treatment for 24 weeks ]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 .
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|