Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 12, 2012
June 1, 2012
1.2 years
June 4, 2012
June 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 .
given atorvastatin 40mg treatment for 24 weeks
Study Arms (2)
Atorvastatin
EXPERIMENTAL30 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.
compare
NO INTERVENTION30 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
FuXing Hospital,Capital Medicial University
Beijing, 100038, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhong Qin, master
science study Dept
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Xu Bin
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 12, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2013
Study Completion
September 1, 2013
Last Updated
June 12, 2012
Record last verified: 2012-06