Vascular Ultrasound Screening in Patients With Ischemic Cerebrovascular Disease: a Multi-center Registry Study
NCT ID: NCT02397655
Last Updated: 2016-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
12012 participants
OBSERVATIONAL
2015-06-30
2016-05-31
Brief Summary
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Detailed Description
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1\. Ultrasound examinations procedures: According to the guidelines of vascular ultrasonography published by the Chinese Medical Doctor Association (CMDA) in 2009. The stenosis degrees of carotid artery, vertebral artery, subclavian artery as well as the middle cerebral artery are evaluated followed the criteria we published previously (references 1-4).
2\. Radiology examinations procedures: Enrolled patients receive CT or MRI examinations to determine the presence and the location of cerebral infarction. If necessary, patients receive CT angiography (CTA) or MRI angiography (MRA) examinations to confirm the degrees of vessel stenosis.
3\. The data collected in this study including:
1. The general informations of enrolled subjects, which include name, gender, age, resident address, telephone number.Each subject is assigned an unique identification number.
2. The history of stroke risk factors, which include 1) hypertension; 2) atrial fibrillation; 3) smoking; 4) dyslipidemia; 5) diabetes mellitus; 6) lack of physical activity (the standard of physical activity is ≥ 3 times per week and ≥30 min per time and the duration time ≥ 1 year);7) obvious overweight or obesity (BMI ≥ 26.0 Kg/m2);8) with family history of stroke.
3. The medicines used within recent 2 weeks, the surgery name (such as stenting, carotid endarterectomy)if any.
4. The results of vascular ultrasonography, ultrasonic cardiogram, radiology examinations, laboratory tests results (blood glucose, lipoproteins pattern, homocystein, C reactive protein, fibrinogen)
4\. Statistic analysis plans The Statistical Package for Social Sciences (SPSS version 22.0) software was used for the statistical analyses.
1. Numerical values are shown as the mean ± standard deviation (SD). The t test or One-way ANOVA is used to compare the numerical values among different groups.
2. Chi square test is used to analyze the influencing factors on the intra-/extra-cranial atherosclerosis distribution patterns and the relationship between vessel stenosis degrees and the occurence of ischemic stroke.
3. Logistic regression is used to analyze the influencing intensity of various risk factors on atherosclerosis and ischemic events.
4. A P value \<0.05 was considered statistically significant.
5\. Quality assurance plans:
1. The medical centers implement the projects are the stroke prevention and treatment base hospitals awarded by National Health and Family Planning Commission, P.R. China. The medical centers have the instruments required in this study.
2. Neurologists, neurosurgeons and vascular ultrasound physicians have received standard training hosted by National Health and Family Planning Commission stroke prevention engineering committee and obtained excellent records.
3. All the centers conduct the project followed the uniform implementation plans and each center guarantee the data input in time and accurately.
4. The project has the unique database and data input in uniform format.
5. There are specific staffs to check the accuracy and completeness of data.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
2. Patients with ischemic stroke including acute and old cerebral infarction.
Exclusion Criteria
2. vessel stenosis or occlusion caused by trauma,dissection or Takayasu's arteritis；
3. Stroke patients caused by patent foramen ovale.
4. Moyamoya disease;
5. Multiple sclerosis;
6. Mitochondrial myopathy.
40 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Shanxi Medical University
OTHER
Liaocheng Brains Hospital
UNKNOWN
Tianjin Huanhu Hospital
OTHER
Baotou Central Hospital
OTHER
The First Hospital of Jilin University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
First Hospital of China Medical University
OTHER
LanZhou University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Anhui Provincial Hospital
OTHER_GOV
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
ZhuHai Hospital
OTHER
Fujian Provincial Hospital
OTHER
Mianyang Central Hospital
OTHER
The Second Affiliated Hospital of Kunming Medical University
OTHER
Brains Hospital of Hunan Province
UNKNOWN
Henan Provincial People's Hospital
OTHER
Luoyang Central Hospital
OTHER
National Health and Family Planning Commission Stroke Prevention Engineering Committee
UNKNOWN
Dalian Municipal Central Hospital
OTHER
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Principal Investigators
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Yang Hua, MD
Role: PRINCIPAL_INVESTIGATOR
No.45, Changchun Road, Xicheng District, Beijing, China 100053
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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References
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Hua Y, Jia L, Li L, Ling C, Miao Z, Jiao L. Evaluation of severe subclavian artery stenosis by color Doppler flow imaging. Ultrasound Med Biol. 2011 Mar;37(3):358-63. doi: 10.1016/j.ultrasmedbio.2010.12.003. Epub 2011 Jan 26.
Hua Y, Meng XF, Jia LY, Ling C, Miao ZR, Ling F, Liu JB. Color Doppler imaging evaluation of proximal vertebral artery stenosis. AJR Am J Roentgenol. 2009 Nov;193(5):1434-8. doi: 10.2214/AJR.09.2624.
Hua Y, Liu BB, Ling C, Duan C, Liu Q, Miao ZR, Li SM, Ling F. Accurate assesment of the diagnosis between 50-69% and 70-99% carotid stenoses with ultrasonography. Chinese Journal of Cerebrovascular Diseases. 3(5): 211-218,2006.
Meng XF, Hua Y, Liu BB, Ling C, Miao ZR, Jiao LQ. The diagnostic accuracy of transcranial doppler ultrasonogrphy for middle cerebral artery stenosis. Chinese Journal of Cerebrovascular Diseases. 7(6): 284-289, 2010.
Liu R, Gao M, Zhao X. Evaluation of collateral circulation in patients with internal carotid artery occlusion: A clinical and ultrasonographic multicenter study. Vasc Med. 2024 Dec;29(6):707-715. doi: 10.1177/1358863X241264759. Epub 2024 Sep 8.
Other Identifiers
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VUS-ICVD
Identifier Type: -
Identifier Source: org_study_id