Stroke
Conditions
Keywords
stroke, ischemia, atherosclerosis, ultrasonography
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.
Interventions
None listed
Sponsors
The First Affiliated Hospital of Shanxi Medical University
Liaocheng Brains Hospital
Tianjin Huanhu Hospital
Baotou Central Hospital
The First Hospital of Jilin University
First Affiliated Hospital of Harbin Medical University
First Hospital of China Medical University
LanZhou University
First Affiliated Hospital of Xinjiang Medical University
The First Affiliated Hospital of Soochow University
Anhui Provincial Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
ZhuHai Hospital
Fujian Provincial Hospital
Mianyang Central Hospital
The Second Affiliated Hospital of Kunming Medical University
Brains Hospital of Hunan Province
Henan Provincial People's Hospital
Luoyang Central Hospital
National Health and Family Planning Commission Stroke Prevention Engineering Committee
Dalian Municipal Central Hospital
Xuanwu Hospital, Beijing
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | 30 days after subjects recruitment | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis. | 10,711 |
| Total | 10,711 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | data not completed | 1,301 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment China | 10711 participants |
| Sex: Female, Male Female | 3628 Participants |
| Sex: Female, Male Male | 7083 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12,012 |
| serious Total, serious adverse events | 0 / 12,012 |
Outcome results
Primary
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.
Time frame: 30 days after subjects recruitment
Population: We provide the vessel numbers with its stenosis degree ≥50% stenosis (including occlusion).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | internal carotid artery ≥50% stenosis | 1063 artery numbers |
| Overall Study | Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | excranial vertebral artery ≥50% stenosis | 826 artery numbers |
| Overall Study | Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | subclavian artery ≥50% stenosis | 241 artery numbers |
| Overall Study | Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | middle cerebral artery ≥50% stenosis | 1810 artery numbers |
| Overall Study | Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | intracranial segment of vertebral artery stenosis | 777 artery numbers |
| Overall Study | Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | common carotid artery ≥50% stenosis | 96 artery numbers |
| Overall Study | Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography | basilar artery ≥50% stenosis | 324 artery numbers |