Reference Values of Carotid Intima-media Thickness and Arterial Stiffness in Chinese Adults Based on Ultrasound Radio Frequency Signal: A Nationwide, Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,500
- 试验地点
- 34
- 主要终点
- Pulse wave velocity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Pulse wave velocity
时间窗: one-time measurement on the day of ultrasound examination
m/sec,one-time measurement throughout the study
Age
时间窗: one-time measurement on the day of ultrasound examination
years, one-time measurement throughout the study
Carotid stiffness index
时间窗: 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
Artery compliance coefficient
时间窗: 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
Intima-media thickness
时间窗: one-time measurement on the day of ultrasound examination
millimeter, one-time measurement throughout the study
次要结局
- Total cholesterol(one-time measurement with 7 days before or after ultrasound examination)
- fasting blood glucose(one-time measurement with 7 days before or after ultrasound examination)
- blood pressure(one-time measurement on the day of ultrasound examination)
- Triglycerides(one-time measurement with 7 days before or after ultrasound examination)
- Height(one-time measurement on the day of ultrasound examination)
- Weight(one-time measurement on the day of ultrasound examination)
研究者
Lijun Yuan, MD, PhD
Director of the department of ultrasound diagnostics
Tang-Du Hospital