Adults, Carotid Intima-media Thickness, Chinese, Healthy, Vascular Stiffness
Conditions
Brief summary
This study intends to establish the normal reference values of carotid artery intima-media thickness and vascular elasticity of Chinese adults based on ultrasound radio frequency technology through a multi-center large-sample study, which provides important information for the risk prediction and prognosis evaluation of Chinese adults' cardiovascular disease.
Detailed description
After being informed about the study, all participants giving written informed consent will undergo a one-time examination of vascular ultrasound, including general characteristics and the target ultrasound parameters. To detect the smallest difference between adjacent age groups within the age range 18-79 (6 groups, α = 0.05, β = 0.20, Statistical Power = 0.80). Given the influence of multiple centers, the minimum sample size is 1800, the optimal sample size is 3500. The male to female ratio is 1:1. Quality Control including the pre-study training and data monitoring during the study.
Interventions
None listed
Sponsors
Esaote (Shenzhen) Medical Equipment Co. Ltd
Zhejiang University
Shannxi Provincial People's Hospital
Shengjing Hospital
First Hospital of China Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Renmin Hospital of Wuhan University
Beijing University of Chinese Medicine Third Affiliated Hospital
The First Affiliated Hospital of Shanxi Medical University
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
The First Hospital of Jilin University
The Afffiliated Hospital of Guizhou Medical University
Yan An Hospital Affiliated to Kunming Medical University
Second Affiliated Hospital of Guangzhou Medical University
The Third Xiangya Hospital of Central South University
Ruijin Hospital
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital of Anhui Medical University
The Second Hospital of Anhui Medical University
The First Affiliated Hospital of USTC
The Affiliated Hospital of Qingdao University
First Affiliated Hospital of Xinjiang Medical University
Hospital of Northwestern Polytechnical University
GEM Flower Xian Changqing Staff Hospital
Xi'an Central Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital of Guangxi Medical University
Karamay Central Hospital of Xinjiang
Fourth Affiliated Hospital of Xinjiang Medical University
Xi'an No.1 Hospital
Xianyang Hospital of Yan'an University
General Hospital of Xinjiang Production and Construction Corps
Air Force Military Medical University, China
Tang-Du Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18-79 * The blood pressure is normal: systolic blood pressure \<140 mmHg, and diastolic blood pressure \<90 mmHg * The physical examination and electrocardiogram are normal
Exclusion criteria
* Subjects with carotid intima-media thickness ≥ 1.0 mm should be excluded; * Subjects with previous cardiovascular disease history and medication history should be excluded. The main diseases include coronary heart disease, congenital heart disease, heart failure, hypertension, stroke, hyperlipidemia, diabetes, aortic arteritis, etc.; * Subjects with past medical history and medication history of endocrine, rheumatism, chronic respiratory disease, liver and kidney disease should be excluded; * Obese subjects (BMI ≥ 28 kg/m2), professional athletes, pregnant and lactating women should be excluded; * Alcohol or drug addicts and smokers who have not quit smoking should be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intima-media thickness | one-time measurement on the day of ultrasound examination | millimeter, one-time measurement throughout the study |
| Carotid stiffness index | one-time measurement on the day of ultrasound examination | =D▪ln(Ps/Pd)/ΔD, D: diastolic carotid diameter; Ps, systolic pressure; Pd, diastolic pressure; ΔD: Change of diameter in systolic. one-time measurement throughout the study |
| Pulse wave velocity | one-time measurement on the day of ultrasound examination | m/sec,one-time measurement throughout the study |
| Artery compliance coefficient | one-time measurement on the day of ultrasound examination | mm2kPa-1; =π▪(2▪D▪ΔD+ΔD2)/4▪ΔP; D: Diastolic diameter; ΔD: Change of diameter in systolic; ΔP, pulse pressure. one-time measurement throughout the study |
| Age | one-time measurement on the day of ultrasound examination | years, one-time measurement throughout the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | one-time measurement on the day of ultrasound examination | mmHg, one-time measurement throughout the study |
| Weight | one-time measurement on the day of ultrasound examination | kg, one-time measurement throughout the study |
| fasting blood glucose | one-time measurement with 7 days before or after ultrasound examination | mmol/L, one-time measurement throughout the study |
| Total cholesterol | one-time measurement with 7 days before or after ultrasound examination | mmol/L, one-time measurement throughout the study |
| Triglycerides | one-time measurement with 7 days before or after ultrasound examination | mmol/L, one-time measurement throughout the study |
| Height | one-time measurement on the day of ultrasound examination | m, one-time measurement throughout the study |
Countries
China
Contacts
Primary ContactChangyang Xing, PhD; MD
Outcome results
None listed