RF Based QIMT & QAS Study on Chinese Adults
- Conditions
- HealthyVascular StiffnessAdultsChineseCarotid Intima-media Thickness
- Registration Number
- NCT04881292
- Lead Sponsor
- Tang-Du Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3500
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Age one-time measurement on the day of ultrasound examination years, 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
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
Intima-media thickness one-time measurement on the day of ultrasound examination millimeter, 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
- Secondary Outcome Measures
Name Time Method Total cholesterol one-time measurement with 7 days before or after ultrasound examination mmol/L, 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
blood pressure one-time measurement on the day of ultrasound examination mmHg, 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
Weight one-time measurement on the day of ultrasound examination kg, one-time measurement throughout the study
Trial Locations
- Locations (34)
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of USTC
🇨🇳Hefei, Anhui, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Air Force Medical Center
🇨🇳Beijing, Beijing, China
Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The Afffiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
🇨🇳Baotou, Inner Mongolia, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Tangdu Hospital, Air Force Medical University
🇨🇳Xi'an, Shannxi, China
Shannxi Provincial People's Hospital
🇨🇳Xi'an, Shannxi, China
GEM Flower Xian Changqing Staff Hospital
🇨🇳Xi'an, Shannxi, China
Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shannxi, China
The Second Affiliated Hospital of Xi'an Medical University
🇨🇳Xi'an, Shannxi, China
Xianyang Hospital of Yan'an University
🇨🇳Xianyang, Shanxi, China
General Hospital of Xinjiang Production and Construction Corps
🇨🇳Urumqi, Xijiang, China
Karamay Central Hospital of Xinjiang
🇨🇳Karamay, Xinjiang, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yan An Hospital Affiliated to Kunming Medical University
🇨🇳Kunming, Yunnan, China
Hospital of Northwestern Polytechnical University
🇨🇳Xi'an, Shannxi, China
Xi'an Central Hospital
🇨🇳Xi'an, Shannxi, China
Xi'an No.1 Hospital
🇨🇳Xi'an, Shannxi, China
Beijing University of Chinese Medicine Third Affiliated Hospital
🇨🇳Beijing, Beijing, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China