Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
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| First Received Date ICMJE | June 4, 2012 | ||||||||
| Last Updated Date | June 11, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 . |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01617538 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis | ||||||||
| Official Title ICMJE | Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis After 24-week Atorvastatin Treatment | ||||||||
| Brief 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. |
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| 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 |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Stenosis | ||||||||
| Intervention ICMJE | Drug: atorvastatin
40mg per day,duration for 24 weeks
Other Name: brand names :FIZER |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01617538 | ||||||||
| Other Study ID Numbers ICMJE | WS1788891-22-CT25 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Bin Xu, MD, Capital Medical University | ||||||||
| Study Sponsor ICMJE | Capital Medical University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Capital Medical University | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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