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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04881292
Other study ID # 20210402V2.0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date May 2022

Study information

Verified date September 2021
Source Tang-Du Hospital
Contact Changyang Xing, PhD; MD
Phone 13571864787
Email xingcy712@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 3500
Est. completion date May 2022
Est. primary completion date May 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology Baotou Inner Mongolia
China Air Force Medical Center Beijing Beijing
China Beijing University of Chinese Medicine Third Affiliated Hospital Beijing Beijing
China The First Hospital of Jilin University Changchun Jilin
China Third Xiangya Hospital of Central South University Changsha Hunan
China Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China The Afffiliated Hospital of Guizhou Medical University Guiyang Guizhou
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
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 Karamay Central Hospital of Xinjiang Karamay Xinjiang
China Yan An Hospital Affiliated to Kunming Medical University Kunming Yunnan
China The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu
China First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
China The Affiliated Hospital of Qingdao University Qingdao Shandong
China Ruijin Hospital Shanghai Shanghai
China First Hospital of China Medical University Shenyang Liaoning
China Shengjing Hospital of China Medical University Shenyang Liaoning
China First Hospital of Shanxi Medical University Taiyuan Shanxi
China First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China General Hospital of Xinjiang Production and Construction Corps Urumqi Xijiang
China The Fourth Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China Renmin Hospital of Wuhan University Wuhan Hubei
China Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
China GEM Flower Xian Changqing Staff Hospital Xi'an Shannxi
China Hospital of Northwestern Polytechnical University Xi'an Shannxi
China Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shannxi
China Shannxi Provincial People's Hospital Xi'an Shannxi
China Tangdu Hospital, Air Force Medical University Xi'an Shannxi
China The Second Affiliated Hospital of Xi'an Medical University Xi'an Shannxi
China Xi'an Central Hospital Xi'an Shannxi
China Xi'an No.1 Hospital Xi'an Shannxi
China Xianyang Hospital of Yan'an University Xianyang Shanxi

Sponsors (35)

Lead Sponsor Collaborator
Tang-Du Hospital Air Force Medical Center, Beijing University of Chinese Medicine Third Affiliated Hospital, Esaote (Shenzhen) Medical Equipment Co. Ltd, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, GEM Flower Xian Changqing Staff Hospital, General Hospital of Xinjiang Production and Construction Corps, Hospital of Northwestern Polytechnical University, Karamay Central Hospital of Xinjiang, Renmin Hospital of Wuhan University, Ruijin Hospital, Second Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Shannxi Provincial People's Hospital, Shengjing Hospital, The Afffiliated Hospital of Guizhou Medical University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, The First Affiliated Hospital of Shanxi Medical University, The First Affiliated Hospital of USTC, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital, Zhejiang University School of Medicine, The First Hospital of Jilin University, The Fourth Affiliated Hospital of Xinjiang Medical University, The Second Affiliated Hospital of Xi'an Medical University, The Second Hospital of Anhui Medical University, Third Xiangya Hospital of Central South University, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Xi'an Central Hospital, Xi'an No.1 Hospital, Xianyang Hospital of Yan'an University, Yan An Hospital Affiliated to Kunming Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intima-media thickness millimeter, one-time measurement throughout the study one-time measurement on the day of ultrasound examination
Primary Carotid stiffness index =D?ln(Ps/Pd)/?D, D: diastolic carotid diameter; Ps, systolic pressure; Pd, diastolic pressure; ?D: Change of diameter in systolic. one-time measurement throughout the study one-time measurement on the day of ultrasound examination
Primary Pulse wave velocity m/sec,one-time measurement throughout the study one-time measurement on the day of ultrasound examination
Primary Artery compliance coefficient mm2kPa-1; =p?(2?D??D+?D2)/4??P; D: Diastolic diameter; ?D: Change of diameter in systolic; ?P, pulse pressure. one-time measurement throughout the study one-time measurement on the day of ultrasound examination
Primary Age years, one-time measurement throughout the study one-time measurement on the day of ultrasound examination
Secondary blood pressure mmHg, one-time measurement throughout the study one-time measurement on the day of ultrasound examination
Secondary fasting blood glucose mmol/L, one-time measurement throughout the study one-time measurement with 7 days before or after ultrasound examination
Secondary Total cholesterol mmol/L, one-time measurement throughout the study one-time measurement with 7 days before or after ultrasound examination
Secondary Triglycerides mmol/L, one-time measurement throughout the study one-time measurement with 7 days before or after ultrasound examination
Secondary Height m, one-time measurement throughout the study one-time measurement on the day of ultrasound examination
Secondary Weight kg, one-time measurement throughout the study one-time measurement on the day of ultrasound examination
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