RF Based QIMT & QAS Study on Chinese Adults

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881292
• Other study ID #: 20210402V2.0
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adults
• Carotid Intima-media Thickness
• Chinese
• Healthy
• Vascular Stiffness

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