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HealthyNCT04881292

RF Based QIMT & QAS Study on Chinese Adults

An observational study of Healthy and Adults, run by Tang-Du Hospital at 34 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Adults, Carotid Intima-media Thickness
How many people
3,500 participants
Where
34 sitesChina
Study dates
1 May 2021to May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy Han Chinese adults

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 1 country.

Changyang Xing, PhD; MD contact

13571864787

xingcy712@163.com

34 sites in 1 country

China34 sites, 34 recruiting

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

    Baotou, Inner Mongolia

    Shiji Wang

    Recruiting

  • Air Force Medical Center

    Beijing, Beijing Municipality

    Bin Ma

    Recruiting

  • Beijing University of Chinese Medicine Third Affiliated Hospital

    Beijing, Beijing Municipality

    Jingfang Dong

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin

    Na Su

    Recruiting

  • Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Wenhui Zhu

    Recruiting

  • Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Lin Mao

    Recruiting

  • The Afffiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Bei Zhang

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310012

    Xiujing Xie

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Xianyue Yang

    Recruiting

  • The First Affiliated Hospital of USTC

    Hefei, Anhui

    Shuqing Jiang

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

    Jun Wu

    Recruiting

  • Karamay Central Hospital of Xinjiang

    Karamay, Xinjiang

    Erke Zhang

    Recruiting

  • Yan An Hospital Affiliated to Kunming Medical University

    Kunming, Yunnan

    Xuan Su

    Recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

    Jianxiang Wang

    Recruiting

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Qiao Que

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Yongmei Sun

    Recruiting

  • Ruijin Hospital

    Shanghai, Shanghai Municipality

    Ri Ji

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Xiaona Yu

    Recruiting

  • First Hospital of China Medical University

    Shenyang, Liaoning

    Huangliang Liu

    Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Qianjun Ye

    Recruiting

  • General Hospital of Xinjiang Production and Construction Corps

    Ürümqi, Xijiang

    Ying Zhuang

    Recruiting

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Ting Ma

    Recruiting

  • The Fourth Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Zhanlei Chen

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    Juhong Pan

    Recruiting

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

    Wuhan, Hubei

    Yu Wu

    Recruiting

  • Tangdu Hospital, Air Force Medical University

    Xi'an, Shannxi, 710038

    Changyang Xing

    Recruiting

  • Shannxi Provincial People's Hospital

    Xi'an, Shannxi, 710068

    Aihua Wei

    Recruiting

  • GEM Flower Xian Changqing Staff Hospital

    Xi'an, Shannxi

    Hao Wang

    Recruiting

  • Hospital of Northwestern Polytechnical University

    Xi'an, Shannxi

    Fan Li

    Recruiting

  • Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shannxi

    Ting Liu

    Recruiting

  • The Second Affiliated Hospital of Xi'an Medical University

    Xi'an, Shannxi

    Hengli Yang

    Recruiting

  • Xi'an Central Hospital

    Xi'an, Shannxi

    Xue Dong

    Recruiting

  • Xi'an No.1 Hospital

    Xi'an, Shannxi

    Xiaojun Zhan

    Recruiting

  • Xianyang Hospital of Yan'an University

    Xianyang, Shanxi

    Bei Jia

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intima-media thickness

    millimeter, one-time measurement throughout the study

    Measured: one-time measurement on the day of ultrasound examination

  2. 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

    Measured: one-time measurement on the day of ultrasound examination

  3. Pulse wave velocity

    m/sec,one-time measurement throughout the study

    Measured: one-time measurement on the day of ultrasound examination

  4. 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

    Measured: one-time measurement on the day of ultrasound examination

  5. Age

    years, one-time measurement throughout the study

    Measured: one-time measurement on the day of ultrasound examination

Secondary outcomes (6)

  1. blood pressure

    mmHg, one-time measurement throughout the study

    Measured: one-time measurement on the day of ultrasound examination

  2. fasting blood glucose

    mmol/L, one-time measurement throughout the study

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

  3. Total cholesterol

    mmol/L, one-time measurement throughout the study

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

  4. Triglycerides

    mmol/L, one-time measurement throughout the study

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

  5. Height

    m, one-time measurement throughout the study

    Measured: one-time measurement on the day of ultrasound examination

  6. Weight

    kg, one-time measurement throughout the study

    Measured: one-time measurement on the day of ultrasound examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2021
  2. Study start1 May 2021
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
3,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881292
Sponsor's protocol ID
20210402V2.0
Status last verified
Sep 2021
First submitted
1 May 2021
Last updated
14 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Adults, run by Tang-Du Hospital at 34 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Changyang Xing, PhD; MD (13571864787, xingcy712@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intima-media thickness (time frame: one-time measurement on the day of ultrasound examination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04881292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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