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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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

Conditions

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Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

atorvastatin

Intervention Type DRUG

40mg per day,duration for 24 weeks

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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atorvastatin

40mg per day,duration for 24 weeks

Intervention Type DRUG

Other Intervention Names

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brand names :FIZER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No