RF Based QIMT & QAS Study on Chinese Adults

NCT ID: NCT04881292

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Healthy Adults Carotid Intima-media Thickness Vascular Stiffness Chinese

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Esaote (Shenzhen) Medical Equipment Co. Ltd

UNKNOWN

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Shannxi Provincial People's Hospital

UNKNOWN

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Beijing University of Chinese Medicine Third Affiliated Hospital

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

The Afffiliated Hospital of Guizhou Medical University

UNKNOWN

Sponsor Role collaborator

Yan An Hospital Affiliated to Kunming Medical University

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Third Xiangya Hospital of Central South University

UNKNOWN

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of USTC

UNKNOWN

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Hospital of Northwestern Polytechnical University

UNKNOWN

Sponsor Role collaborator

GEM Flower Xian Changqing Staff Hospital

UNKNOWN

Sponsor Role collaborator

Xi'an Central Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Karamay Central Hospital of Xinjiang

UNKNOWN

Sponsor Role collaborator

Fourth Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Xi'an No.1 Hospital

UNKNOWN

Sponsor Role collaborator

Xianyang Hospital of Yan'an University

UNKNOWN

Sponsor Role collaborator

General Hospital of Xinjiang Production and Construction Corps

UNKNOWN

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lijun Yuan, MD, PhD

Director of the department of ultrasound diagnostics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lijun Yuan, PhD; MD

Role: PRINCIPAL_INVESTIGATOR

Tangdu Hospital-Air Force Medical University

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Site Status RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Air Force Medical Center

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing University of Chinese Medicine Third Affiliated Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

The Afffiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

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

Baotou, Inner Mongolia, China

Site Status RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Tangdu Hospital, Air Force Medical University

Xi'an, Shannxi, China

Site Status RECRUITING

Shannxi Provincial People's Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

GEM Flower Xian Changqing Staff Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Hospital of Northwestern Polytechnical University

Xi'an, Shannxi, China

Site Status RECRUITING

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shannxi, China

Site Status RECRUITING

The Second Affiliated Hospital of Xi'an Medical University

Xi'an, Shannxi, China

Site Status RECRUITING

Xi'an Central Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Xi'an No.1 Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status RECRUITING

Xianyang Hospital of Yan'an University

Xianyang, Shanxi, China

Site Status RECRUITING

General Hospital of Xinjiang Production and Construction Corps

Ürümqi, Xijiang, China

Site Status RECRUITING

Karamay Central Hospital of Xinjiang

Karamay, Xinjiang, China

Site Status RECRUITING

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

The Fourth Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status RECRUITING

Yan An Hospital Affiliated to Kunming Medical University

Kunming, Yunnan, China

Site Status RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Changyang Xing, PhD; MD

Role: CONTACT

13571864787

Facility Contacts

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Xianyue Yang

Role: primary

Shuqing Jiang

Role: primary

Jun Wu

Role: primary

Bin Ma

Role: primary

Jingfang Dong

Role: primary

Lin Mao

Role: primary

Qiao Que

Role: primary

Bei Zhang

Role: primary

Juhong Pan

Role: primary

Yu Wu

Role: primary

Wenhui Zhu

Role: primary

Shiji Wang

Role: primary

Jianxiang Wang

Role: primary

Na Su

Role: primary

Xiaona Yu

Role: primary

Huangliang Liu

Role: primary

Yongmei Sun

Role: primary

Ri Ji

Role: primary

Changyang Xing

Role: primary

Aihua Wei

Role: primary

Hao Wang

Role: primary

Fan Li

Role: primary

Ting Liu

Role: primary

Hengli Yang

Role: primary

Xue Dong

Role: primary

Xiaojun Zhan

Role: primary

Qianjun Ye

Role: primary

Bei Jia

Role: primary

Ying Zhuang

Role: primary

Erke Zhang

Role: primary

Ting Ma

Role: primary

Zhanlei Chen

Role: primary

Xuan Su

Role: primary

Xiujing Xie

Role: primary

Other Identifiers

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20210402V2.0

Identifier Type: -

Identifier Source: org_study_id

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