Clinical trial NCT02397655: Vascular Ultrasound Screening in Patients With Ischemic Cerebrovascular Disease: a Multi-center Registry Study
Official title: Screening Carotid Artery and Intracranial Arteries by Ultrasound in Chinese Population With Transient Ischemic Attack and Ischemic Stroke: a Multi-center Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
ischemia
atherosclerosis
ultrasonography
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Shanxi Medical University
name: Liaocheng Brains Hospital
name: Tianjin Huanhu Hospital
name: Baotou Central Hospital
name: The First Hospital of Jilin University
name: First Affiliated Hospital of Harbin Medical University
name: First Hospital of China Medical University
name: LanZhou University
name: First Affiliated Hospital of Xinjiang Medical University
name: The First Affiliated Hospital of Soochow University
name: Anhui Provincial Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: ZhuHai Hospital
name: Fujian Provincial Hospital
name: Mianyang Central Hospital
name: The Second Affiliated Hospital of Kunming Medical University
name: Brains Hospital of Hunan Province
name: Henan Provincial People's Hospital
name: Luoyang Central Hospital
name: National Health and Family Planning Commission Stroke Prevention Engineering Committee
name: Dalian Municipal Central Hospital
First posted: 2015-03-25
Enrollment: 12012
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In hospital patients with transient ischemic attack and ischemic stroke.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography
timeFrame: 30 days after subjects recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: No.45, Changchun Road, Xicheng District, Beijing, China 100053
name: Yang Hua, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.