Vascular Ultrasound Screening in Patients With Ischemic Cerebrovascular Disease: a Multi-center Registry Study

Screening Carotid Artery and Intracranial Arteries by Ultrasound in Chinese Population With Transient Ischemic Attack and Ischemic Stroke: a Multi-center Registry Study

The purpose of this multicenter study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations with transient ischemic attack and ischemic stroke and analyze the influencing factors of atherosclerosis distribution pattern.

Study Overview

• Status: Completed
• Conditions: Stroke

Detailed Description

In this multicenter study, carotid artery color doppler flow imaging and transcranial color code doppler or transcranial doppler will be used to screen the extra-/intra-cranial vessels in chinese populations with transient ischemic attack and ischemic stroke. The aim of this study is to investigate the extra-/intra-cranial atherosclerosis distribution pattern in chinese populations and analyze the influencing factors of atherosclerosis distribution pattern.

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.

• Study Type: Observational
• Enrollment (Actual): 12012

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In hospital patients with transient ischemic attack and ischemic stroke.

Description

Inclusion Criteria: Hospitalized patients with age range ≥40 years and meet one of the following two criteria.

1. Patients with transient ischemic attack in recent 3 months.
2. Patients with ischemic stroke including acute and old cerebral infarction.

Exclusion Criteria:

1. cerebral hemorrhage;
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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography	By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion. By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion. Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree.	30 days after subjects recruitment

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; LanZhou University; The First Affiliated Hospital of Soochow University; The First Hospital of Jilin University; Henan Provincial People's Hospital; First Hospital of China Medical University; The First Affiliated Hospital of Shanxi Medical University; First Affiliated Hospital of Xinjiang Medical University; Fujian Provincial Hospital; First Affiliated Hospital of Harbin Medical University; Anhui Provincial Hospital; Mianyang Central Hospital; The Second Affiliated Hospital of Kunming Medical University; ZhuHai Hospital; Luoyang Central Hospital; Baotou Central Hospital; Tianjin Huanhu Hospital; Dalian Municipal Central Hospital; Liaocheng Brains Hospital; Brains Hospital of Hunan Province; National Health and Family Planning Commission Stroke Prevention Engineering Committee
• Investigators: Principal Investigator: Yang Hua, MD, No.45, Changchun Road, Xicheng District, Beijing, China 100053

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (ESTIMATE): March 25, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): November 4, 2016
• Last Update Submitted That Met QC Criteria: September 18, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: stroke; atherosclerosis; ischemia; ultrasonography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: VUS-ICVD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO