RF Based QIMT & QAS Study on Chinese Adults

NCT04881292 | Unknown

• 1 other identifier: 20210402V2.0
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 34

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• blood pressure

  one-time measurement on the day of ultrasound examination

• fasting blood glucose

  one-time measurement with 7 days before or after ultrasound examination

• Total cholesterol

  one-time measurement with 7 days before or after ultrasound examination

• Triglycerides

  one-time measurement with 7 days before or after ultrasound examination

• Height

  one-time measurement on the day of ultrasound examination

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Han Chinese adults

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (34)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

The First Affiliated Hospital of USTC

Hefei, Anhui, China

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Air Force Medical Center

Beijing, Beijing Municipality, China

RECRUITING

Beijing University of Chinese Medicine Third Affiliated Hospital

Beijing, Beijing Municipality, China

RECRUITING

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

The Afffiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China

RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Tangdu Hospital, Air Force Medical University

Xi'an, Shannxi, 710038, China

RECRUITING

Shannxi Provincial People's Hospital

Xi'an, Shannxi, 710068, China

RECRUITING

GEM Flower Xian Changqing Staff Hospital

Xi'an, Shannxi, China

RECRUITING

Hospital of Northwestern Polytechnical University

Xi'an, Shannxi, China

RECRUITING

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shannxi, China

RECRUITING

The Second Affiliated Hospital of Xi'an Medical University

Xi'an, Shannxi, China

RECRUITING

Xi'an Central Hospital

Xi'an, Shannxi, China

RECRUITING

Xi'an No.1 Hospital

Xi'an, Shannxi, China

RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

RECRUITING

Xianyang Hospital of Yan'an University

Xianyang, Shanxi, China

RECRUITING

General Hospital of Xinjiang Production and Construction Corps

Ürümqi, Xijiang, China

RECRUITING

Karamay Central Hospital of Xinjiang

Karamay, Xinjiang, China

RECRUITING

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

RECRUITING

The Fourth Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

RECRUITING

Yan An Hospital Affiliated to Kunming Medical University

Kunming, Yunnan, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310012, China

RECRUITING

Study Officials

• Lijun Yuan, PhD; MD

  Tangdu Hospital-Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changyang Xing, PhD; MD

CONTACT

13571864787; xingcy712@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of ultrasound diagnostics

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 11, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication
• 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

Locations

CN (34)