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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397655
• Other study ID #: VUS-ICVD
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: July 12, 2016
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12012
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (22)

Lead Sponsor

Collaborator

Xuanwu Hospital, Beijing

Anhui Provincial Hospital, Baotou City Central Hospital, Brains Hospital of Hunan Province, Dalian Municipal Central Hospital, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, First Hospital of Jilin University, Fujian Provincial Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Henan Provincial Hospital, LanZhou University, Liaocheng Brains Hospital, Luoyang Central Hospital Affiliated to Zhengzhou University, Mianyang Central Hospital, National Health and Family Planning Commission Stroke Prevention Engineering Committee, The First Affiliated Hospital of Shanxi Medical University, The First Affiliated Hospital of Soochow University, The Second Affiliated Hospital of Kunming Medical University, Tianjin Huanhu Hospital, ZhuHai Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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.

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evidence of carotid artery or intracranial artery atherosclerosis confirmed by vascular ultrasonography		30 days after subjects recruitment	No