Healthy Clinical Trial
Official title:
Reference Values of Carotid Intima-media Thickness and Arterial Stiffness in Chinese Adults Based on Ultrasound Radio Frequency Signal: A Nationwide, Multicenter Study
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 |
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.
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. |
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 |
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 |
China,
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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