Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stenosis |
Drug: atorvastatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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 .
| Estimated Enrollment: | 30 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Atorvastatin
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.
|
Drug: atorvastatin
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.
|
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| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Xu Bin, master | 86-010-88062285 | xubincj1992@yahoo.com.cn |
| Contact: Zheng Shanshan, master | 86-010-88062032 | zheng-shan-shan@163.com |
| China | |
| FuXing Hospital,Capital Medicial University | Recruiting |
| Beijing, China, 100038 | |
| Contact: Xu Bin, master 86-010-88062285 xubincj1992@yahoo.com.cn | |
| Principal Investigator: Xu Bin, master | |
| Study Director: | Zhong Qin, master | science study Dept |
More Information
No publications provided
| Responsible Party: | Bin Xu, MD, Xu Bin, Capital Medical University |
| ClinicalTrials.gov Identifier: | NCT01617538 History of Changes |
| Other Study ID Numbers: | WS1788891-22-CT25 |
| Study First Received: | June 4, 2012 |
| Last Updated: | June 11, 2012 |
| Health Authority: | China: Beijing Municipal Science and Technology Commission |
Keywords provided by Capital Medical University:
|
atherosclerosis stenosis statin therapy Signs and Symptoms Circulatory; Change |
Additional relevant MeSH terms:
|
Constriction, Pathologic Pathological Conditions, Anatomical Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013