Chinese Arteriosclerosis Series Evaluation-She Minority Study

Vascular Disease Clinical Trial

— CASE-SMS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02933957
• Other study ID #: PUShougangH
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2016
• Last updated: October 13, 2016
• Start date: January 2015

Study information

• Verified date: October 2016
• Source: Peking University Shougang Hospital
• Contact: Hong yu Wang, Doctor
• Phone: +8610-57830226
• Email: hongyuwang[@]188.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Traditionally, people have always been focusing on vascular injuries by angiography. Recent years, the investigators have further known that the pathological foundation of various cardiovascular complications not only lies in the vascular lumen, but also vessel wall. Therefore, now it is possible to detect and prevent vascular disease early. There are many influencing factors on functional and structural damages of vessels, including genetic and environmental factors. The investigators have done many researches on populations of the Han nationality, which has the largest population in China. Thus, the investigators further wonder whether the function and structure of vessel differ in the She Minority of a remote southern region in China. The investigators will enroll 150 subjects of two ethnic groups respectively in the local population， namely She Minority and Han nationality. All subjects enrolled into the study will complete a questionnaire survey of the general situation and conduct vascular related examinations, including evaluation of arterial stiffness, arterial elasticity indexes, subclinical carotid atherosclerosis and biomarkers. The investigators will analysis vascular differences between the two populations and provide a theoretical basis for the specific strategies of prevention and treatment.

Description:

Population Subjects volunteered to participate the study will be all enrolled into the study. The study is designed to enroll subjects from two ethnic groups in the local population, namely She Minority and Han nationality. All participants will be asked to sign a written informed consent and the study has been approved by the hospital.

Methods

1. Questionnaire The questionnaire survey included family history, disease history (including coronary artery disease, cerebrovascular disease, hypertension, diabetes mellitus, peripheral artery disease), medication history (including cardiovascular drugs, hypertension drugs, diabetes drugs, lipid-lowering drugs), physical activity, smoking condition, drinking status, dietary and life habits etc.

2. Arterial stiffness by vascular function apparatus Arterial stiffness is assessed by brachial-ankle pulse wave velocity (ba-PWV) using an automatic vascular function apparatus. Subjects lie on the detection bed resting about 10 minutes and the apparatus record the value of ba-PWV automatically.

3. Peripheral artery detection by vascular function apparatus Ankle-brachial index (ABI) is used as an evaluation index of peripheral artery and can be measured by an automatic vascular function apparatus.

During the detection of ABI, the blood pressure of the four limbs will be measured simultaneously.

4. Arterial elasticity indexes by carotid ultrasound apparatus A Doppler ultrasound apparatus with a built-in software named quality arterial stiffness (QAS) will be used to measure arterial elasticity indexes, including stiffness coefficient β, pressure strain elastic coefficient, arterial compliance etc.

5. Subclinical carotid atherosclerosis by carotid ultrasound apparatus Assessment indexes of subclinical atherosclerosis including carotid intima-media thickness (IMT), carotid plaque, carotid internal diameter， carotid blood flow peak velocity, diastolic peak velocity of carotid artery, average velocity, resistance index (RI) and pulsation index (PI) will be measured by Doppler ultrasound apparatus.

A more qualified detection of IMT will be also complete by a Doppler ultrasound apparatus with a built-in software named quality intima-media thickness (QIMT).

6. Vascular endothelial function detection Vascular endothelial function will be assessed by a noninvasive method of brachial ultrasound, named flow mediated dilation (FMD). Subjects lie on the detection bed resting 10 minutes and the operator will detect two times of the brachial artery diameter before and after hyperemia.

7. Biomarkers Biomarkers including fasting plasma glucose, plasma lipids (including total cholesterol, triglyceride, low density lipoprotein cholesterol, high density lipoprotein cholesterol), blood uric acid, blood urea nitrogen, creatinine, high sensitive C reactive protein, homocysteine lipoprotein a, Apolipoprotein A1, Apolipoprotein B, glycosylated hemoglobin, insulin, C-peptide etc.

Statistical analysis The investigators will take the double input and check all data. Statistical Product and Service Solutions (SPSS Version 20.0 ) will be the software of analyzing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Voluntary participation

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Locations

Country	Name	City	State
China	Peking University Shougang Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Shougang Hospital	MinDong Hospital of Ningde City

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	value of brachial ankle pulse wave velocity		one and a half years	Yes
Secondary	Percentage of flow mediated dilation		one and a half years	Yes
Secondary	Value of arterial elasticity including stiffness coefficient ß, pressure strain elastic coefficient, arterial compliance		one and a half years	Yes
Secondary	Thickness of carotid intima-media by carotid ultrasound	Carotid ultrasound will be used to measure the thickness of carotid intimate-media.	one and a half years	Yes
Secondary	Presence of Carotid Plaque	Carotid ultrasound will be used to measure the presence of carotid plaque according to Mannheim Consensus	one and a half years	Yes
Secondary	Number of peripheral arteriosclerosis occlusion measured by ankle brachial index		one and a half years	Yes