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Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Capital Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bin Xu, MD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01617538
First received: June 4, 2012
Last updated: June 11, 2012
Last verified: June 2012

June 4, 2012
June 11, 2012
January 2012
March 2013   (final data collection date for primary outcome measure)
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 .
Same as current
Complete list of historical versions of study NCT01617538 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis After 24-week Atorvastatin Treatment

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.

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

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stenosis
Drug: atorvastatin
40mg per day,duration for 24 weeks
Other Name: brand names :FIZER
  • 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.
    Intervention: Drug: atorvastatin
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
40 Years to 90 Years
No
Contact: Xu Bin, master 86-010-88062285 xubincj1992@yahoo.com.cn
Contact: Zheng Shanshan, master 86-010-88062032 zheng-shan-shan@163.com
China
 
NCT01617538
WS1788891-22-CT25
No
Bin Xu, MD, Capital Medical University
Capital Medical University
Not Provided
Study Director: Zhong Qin, master science study Dept
Capital Medical University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP