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
  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

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617538

Contacts
Contact: Xu Bin, master 86-010-88062285 xubincj1992@yahoo.com.cn
Contact: Zheng Shanshan, master 86-010-88062032 zheng-shan-shan@163.com

Locations
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         
Sponsors and Collaborators
Capital Medical University
Investigators
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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014