Clinical trial NCT04881292: RF Based QIMT & QAS Study on Chinese Adults
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Adults
Carotid Intima-media Thickness
Vascular Stiffness
Chinese
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Esaote (Shenzhen) Medical Equipment Co. Ltd
name: Zhejiang University
name: Shannxi Provincial People's Hospital
name: Shengjing Hospital
name: First Hospital of China Medical University
name: Wuhan Union Hospital, China
name: Renmin Hospital of Wuhan University
name: Beijing University of Chinese Medicine Third Affiliated Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
name: The First Hospital of Jilin University
name: The Afffiliated Hospital of Guizhou Medical University
name: Yan An Hospital Affiliated to Kunming Medical University
name: Second Affiliated Hospital of Guangzhou Medical University
name: Third Xiangya Hospital of Central South University
name: Ruijin Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: The First Affiliated Hospital of Anhui Medical University
name: The Second Hospital of Anhui Medical University
name: The First Affiliated Hospital of USTC
name: The Affiliated Hospital of Qingdao University
name: First Affiliated Hospital of Xinjiang Medical University
name: Hospital of Northwestern Polytechnical University
name: GEM Flower Xian Changqing Staff Hospital
name: Xi'an Central Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: First Affiliated Hospital of Guangxi Medical University
name: Karamay Central Hospital of Xinjiang
name: Fourth Affiliated Hospital of Xinjiang Medical University
name: Xi'an No.1 Hospital
name: Xianyang Hospital of Yan'an University
name: General Hospital of Xinjiang Production and Construction Corps
name: Air Force Military Medical University, China
First posted: 2021-05-11
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Han Chinese adults

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intima-media thickness
timeFrame: one-time measurement on the day of ultrasound examination
measure: Carotid stiffness index
timeFrame: one-time measurement on the day of ultrasound examination
measure: Pulse wave velocity
timeFrame: one-time measurement on the day of ultrasound examination
measure: Artery compliance coefficient
timeFrame: one-time measurement on the day of ultrasound examination
measure: Age
timeFrame: one-time measurement on the day of ultrasound examination
Secondary outcomes:
measure: blood pressure
timeFrame: one-time measurement on the day of ultrasound examination
measure: fasting blood glucose
timeFrame: one-time measurement with 7 days before or after ultrasound examination
measure: Total cholesterol
timeFrame: one-time measurement with 7 days before or after ultrasound examination
measure: Triglycerides
timeFrame: one-time measurement with 7 days before or after ultrasound examination
measure: Height
timeFrame: one-time measurement on the day of ultrasound examination
measure: Weight
timeFrame: one-time measurement on the day of ultrasound examination
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Air Force Medical Center
state: Beijing
city: Beijing
country: China
facility: Beijing University of Chinese Medicine Third Affiliated Hospital
state: Beijing
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Guiyang
country: China
facility: The Afffiliated Hospital of Guizhou Medical University
state: Guizhou
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Third Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
state: Inner Mongolia
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital, Air Force Medical University
state: Shannxi
city: Xi'an
country: China
facility: Shannxi Provincial People's Hospital
state: Shannxi
city: Xi'an
country: China
facility: GEM Flower Xian Changqing Staff Hospital
state: Shannxi
city: Xi'an
country: China
facility: Hospital of Northwestern Polytechnical University
state: Shannxi
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi'an Jiaotong University
state: Shannxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Medical University
state: Shannxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shannxi
city: Xi'an
country: China
facility: Xi'an No.1 Hospital
state: Shannxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shanxi
city: Urumqi
country: China
facility: General Hospital of Xinjiang Production and Construction Corps
state: Xijiang
city: Karamay
country: China
facility: Karamay Central Hospital of Xinjiang
state: Xinjiang
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Urumqi
country: China
facility: The Fourth Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yan An Hospital Affiliated to Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Tangdu Hospital, Air Force Medical University
name: Lijun Yuan, PhD; MD
role: PRINCIPAL_INVESTIGATOR
References: