RF Based QIMT & QAS Study on Chinese Adults

Reference Values of Carotid Intima-media Thickness and Arterial Stiffness in Chinese Adults Based on Ultrasound Radio Frequency Signal: A Nationwide, Multicenter Study

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Vascular Stiffness; Adults; Chinese; Carotid Intima-media Thickness

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.

• Study Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

• Study Contact: Name: Changyang Xing, PhD; MD; Phone Number: 13571864787; Email: xingcy712@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Xianyue Yang
    • Hefei, Anhui, China
      • Recruiting
      • The Second Hospital of Anhui Medical University
      • Contact: Jun Wu
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated hospital of USTC
      • Contact: Shuqing Jiang
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Air Force Medical Center
      • Contact: Bin Ma
    • Beijing, Beijing, China
      • Recruiting
      • Beijing University of Chinese Medicine Third Affiliated Hospital
      • Contact: Jingfang Dong
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Second Affiliated Hospital of Guangzhou Medical University
      • Contact: Lin Mao
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • First Affiliated Hospital of Guangxi Medical University
      • Contact: Qiao Que
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • The Afffiliated Hospital of Guizhou Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Juhong Pan
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Yu Wu
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Third Xiangya Hospital of Central South University
      • Contact: Wenhui Zhu
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Recruiting
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
      • Contact: Shiji Wang
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Contact: Jianxiang Wang
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Na Su
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shengjing Hospital of China Medical University
      • Contact: Xiaona Yu
    • Shenyang, Liaoning, China
      • Recruiting
      • First Hospital of China Medical University
      • Contact: Huangliang Liu
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Yongmei Sun
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital
      • Contact: Ri Ji
  • Shannxi
    • Xi'an, Shannxi, China, 710038
      • Recruiting
      • Tangdu Hospital, Air Force Medical University
      • Contact: Changyang Xing
    • Xi'an, Shannxi, China, 710068
      • Recruiting
      • Shannxi Provincial People's Hospital
      • Contact: Aihua Wei
    • Xi'an, Shannxi, China
      • Recruiting
      • GEM Flower Xian Changqing Staff Hospital
      • Contact: Hao Wang
    • Xi'an, Shannxi, China
      • Recruiting
      • Hospital of Northwestern Polytechnical University
      • Contact: Fan Li
    • Xi'an, Shannxi, China
      • Recruiting
      • Second Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Ting Liu
    • Xi'an, Shannxi, China
      • Recruiting
      • The Second Affiliated Hospital of Xi'an Medical University
      • Contact: Hengli Yang
    • Xi'an, Shannxi, China
      • Recruiting
      • Xi'an Central Hospital
      • Contact: Xue Dong
    • Xi'an, Shannxi, China
      • Recruiting
      • Xi'an No.1 Hospital
      • Contact: Xiaojun Zhan
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • First Hospital of Shanxi Medical University
      • Contact: Qianjun Ye
    • Xianyang, Shanxi, China
      • Recruiting
      • Xianyang Hospital of Yan'an University
      • Contact: Bei Jia
  • Xijiang
    • Urumqi, Xijiang, China
      • Recruiting
      • General Hospital of Xinjiang Production and Construction Corps
      • Contact: Ying Zhuang
  • Xinjiang
    • Karamay, Xinjiang, China
      • Recruiting
      • Karamay Central Hospital of Xinjiang
      • Contact: Erke Zhang
    • Urumqi, Xinjiang, China
      • Recruiting
      • First Affiliated Hospital of Xinjiang Medical University
      • Contact: Ting Ma
    • Urumqi, Xinjiang, China
      • Recruiting
      • The Fourth Affiliated Hospital of Xinjiang Medical University
      • Contact: Zhanlei Chen
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Yan An Hospital Affiliated to Kunming Medical University
      • Contact: Xuan Su
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310012
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Xiujing Xie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Han Chinese adults

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intima-media thickness	millimeter, one-time measurement throughout the study	one-time measurement on the day of ultrasound examination
Carotid stiffness index	=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	one-time measurement on the day of ultrasound examination
Pulse wave velocity	m/sec,one-time measurement throughout the study	one-time measurement on the day of ultrasound examination
Artery compliance coefficient	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	one-time measurement on the day of ultrasound examination
Age	years, one-time measurement throughout the study	one-time measurement on the day of ultrasound examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	mmHg, one-time measurement throughout the study	one-time measurement on the day of ultrasound examination
fasting blood glucose	mmol/L, one-time measurement throughout the study	one-time measurement with 7 days before or after ultrasound examination
Total cholesterol	mmol/L, one-time measurement throughout the study	one-time measurement with 7 days before or after ultrasound examination
Triglycerides	mmol/L, one-time measurement throughout the study	one-time measurement with 7 days before or after ultrasound examination
Height	m, one-time measurement throughout the study	one-time measurement on the day of ultrasound examination
Weight	kg, one-time measurement throughout the study	one-time measurement on the day of ultrasound examination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20210402V2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No