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

Primary Purpose

Stenosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
atorvastatin
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stenosis focused on measuring atherosclerosis, stenosis, statin therapy, Signs and Symptoms, Circulatory; Change

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FuXing Hospital,Capital Medicial UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Atorvastatin

compare

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemodynamics changes and MCA stenosis
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 .

Secondary Outcome Measures

Full Information

First Posted
June 4, 2012
Last Updated
June 11, 2012
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01617538
Brief Title
Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
Official Title
Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis After 24-week Atorvastatin Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis
Keywords
atherosclerosis, stenosis, statin therapy, Signs and Symptoms, Circulatory; Change

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
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.
Arm Title
compare
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
brand names :FIZER
Intervention Description
40mg per day,duration for 24 weeks
Primary Outcome Measure Information:
Title
Hemodynamics changes and MCA stenosis
Description
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 .
Time Frame
given atorvastatin 40mg treatment for 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Bin, master
Phone
86-010-88062285
Email
xubincj1992@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng Shanshan, master
Phone
86-010-88062032
Email
zheng-shan-shan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Qin, master
Organizational Affiliation
science study Dept
Official's Role
Study Director
Facility Information:
Facility Name
FuXing Hospital,Capital Medicial University
City
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Bin, master
Phone
86-010-88062285
Email
xubincj1992@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xu Bin, master

12. IPD Sharing Statement

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

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