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Carotid Artery DiseasesNCT03351127

Multicenter Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV)

An observational study of Carotid Artery Diseases and Healthy Volunteers, run by Shengjing Hospital at 44 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To establish the range of BS and ES (m/s) of normal carotid artery by using ultrafast pulse wave velocity (UFPWV), and to explore the influencing factors. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Carotid Artery Diseases, Healthy Volunteers
What is being tested?
Carotid ultrasound examination
Type of treatment
Surgery or procedure
How many people
1,200 participants
Where
44 sitesChina
Study dates
1 Oct 2017to 31 Dec 2024
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: 1200 healthy adults with normal physical examination items will be selected from the physical examination center. According to sex and age stratification, totally 1200 cases will contain 600 males and 600 females. From 18 to 79 years old, they will be divided into 6 groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years and 70-79 years (n=200 per group).

Who may be able to join

  • Han nationality
  • Age between 18 and 79 years old
  • Normal body mass index (18-25 kg/m2)
  • Normal blood pressure (139-90/89-60 mmHg)
  • No history of cardiovascular disease or respiratory diseases
  • Physical examination reveals no abnormalities in cardiovascular and respiratory systems
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  • Normal blood glucose, blood lipid and electrocardiogram (ECG)
  • Echocardiography shows no structural heart disease and normal cardiac function
  • Normal carotid ultrasound
  • No history of cardiovascular drug use

Who cannot join

  • Heart valve regurgitation with clinical significance or moderate symptom and above
  • Respiratory system disease: acute or chronic respiratory disease
  • Endocrine diseases: thyroid disease, diabetes mellitus, aldosteronism, pheochromocytoma, and adrenal cortex dysfunction.
  • Metabolic syndrome
  • Anemia
  • Pregnant or lactating women
Show all 13Show fewer
  • Abnormal liver function (more than twice the normal upper limit), abnormal renal function (creatinine > 2 mg/dl), total cholesterol > 190 mg/dl. If Pro-BNP is detected, Pro-BNP is abnormal or in high limit of normal value.
  • Connective tissue disease
  • Tumor
  • Aortic and peripheral vascular diseases: aortic dilatation, aortic dissection, coarctation of the aorta, polyarteritis, atherosclerosis
  • Daily drinking: liquor greater than 50 ml; red wine more than 100 ml; beer more than 300 ml
  • Professional sportsman
  • The poor quality of ultrasonic images cannot meet parameter measurement and analysis

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • Civil Aviation General Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • The Second Xiangya Hospital of Central South University

    Changsha, Hu'nan

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • University-Town Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 401331

  • Central Hospital of Chongqing Three Gorges

    Chongqing, Chongqing Municipality, 404000

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • Dalian Municipal Central Hospital

    Dalian, Liaoning, 116033

  • Guangdong Second Traditional Chinese Medicine Hospital

    Guangzhou, Guangdong, 510405

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong, 518034

  • Huadu District People's Hospital of Guangzhou

    Guangzhou, Guangdong

  • The Fifth Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Hangzhou Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang, 310007

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • First Affiliated Hospital, Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

  • The First Affiliated Hospital of He'nan University of Science and Technology

    Luoyang, He'nan

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu

  • Jiangsu Provincial Geriatric Hospital

    Nanjing, Jiangsu

  • Ningbo First Hospital

    Ningbo, Zhejiang

  • The First People's Hospital of Pingdingshan of He'nan Province

    Pingdingshan, He'nan

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning

  • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning

  • Hebei General Hospital

    Shijiazhuang, Hebei, 050000

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

  • The First Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • The Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

    Ürümqi, Xinjiang

  • Wuchang Hospital of Hubei Province

    Wuhan, Hubei, 430063

  • The Central Hospital of Wuhan

    Wuhan, Hubei

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

    Wuhan, Hubei

  • Xinxiang Central Hospital

    Xinxiang, He'nan

  • Yan'an University Affiliated Hospital

    Yan’an, Shanxi

  • Zhengzhou Tumor Hospital Affiliated to He'nan University

    Zhengzhou, He'nan, 450000

  • He'nan Provincial People's Hospital

    Zhengzhou, He'nan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, He'nan

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, He'nan

Other trials in China

About this study

Official title: The Multi-center Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Chinese Han Adults (CAR-PWV Study）

To establish the range of BS and ES (m/s) of normal carotid artery by using ultrafast pulse wave velocity (UFPWV), and to explore the influencing factors.

Read the detailed description

With the gradual aging of Chinese population and continuous development of economy and society, the incidence of cardiovascular disease and the number of patients have increased rapidly. The National Heart Center has reported that the number of patients with clinically diagnosed cardiovascular disease in China has reached 290 million in 2016 (240 million in 2014). Cardiovascular disease is the most common cause of death in humans, accounting for nearly 60% of all deaths worldwide. The updated data from World Health Organization (WHO) in 2008 have shown that atherosclerosis and hypertension are the major diseases of the cardiovascular system. Therefore, early detection of arteriosclerosis, timely treatment and early evaluation of therapeutic efficacy are of great significance for the overall control and reduction of the incidence and mortality of cardiovascular disease.

Carotid artery intima-media thickness (IMT) is often used to evaluate early atherosclerosis, but IMT reflects the change of vascular wall structure. In the early stage of atherosclerosis, the changes of vascular elasticity and resistance occur earlier than those of arterial wall thickening. Therefore, accurate evaluation of vascular function plays an important role in the early diagnosis of atherosclerosis.

Basic and clinical studies and clinical data have shown that pulse wave velocity (PWV) is a reliable index for early evaluation of atherosclerosis. The blood is pumped from the left ventricle during systole, and travels along the arterial system to form pulse wave. Its propagation velocity between two fixed points is the PWV. Atherosclerosis leads to the increased PWV. The detection of PWV can accurately reflect the distensibility and stiffness of arterial wall, thereby early detecting atherosclerosis.

There are three main methods for non-invasive pulse wave measurement: Photoelectric sensor is used to measure and record photoplethysmography signal. Pressure sensor is utilized to record pressure wave signals produced by arterial pulsation on the body surface. Ultrasonic Doppler sensor is applied to collect photoplethysmography signal. Photoelectric sensor acquisition system is difficult to distinguish the pulse waves between the large artery and the capillary arteriole, cannot detect the signal of the deep aorta, is easily affected by the electrical signals of perivascular tissue, and has not been widely used in the clinic. Pressure sensor can be used to collect pressure wave signals, such as brachial-ankle pulse wave. This method has relatively low cost, is often used in clinic, but cannot directly get the pulse wave form and the distance of blood vessel, has many influencing factors and low accuracy. Ultrasonic Doppler technique, such as Echo Tracking and QSA, can reveal deep vein pulse waveforms. However, limited by the traditional ultrasonic processing platform, signal acquisition and formula calculation are complex, and the repeatability is poor. Therefore, the clinical application value is limited. It is urgent to establish a new, simple and precise method for the detection of PWV.

Being tested
Carotid ultrasound examination
Medical subject headings
Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carotid ultrasound examinationRadiation

    Carotid pulse wave velocity of all participants were measured by ultrafast ultrasound imaging technology using SuperSonic Imagine's Aixplorer ultrasound system.

Study groups in NCT03351127
Study groupRoleWhat they receive
18-29 year-old groupBased on the inclusion crtiteria, 200 healthy Han people at aged 18-29 and both sexes will be recruited in the analysis. Normal reference values of ultrafast pulse wave velocity will be obtained.
Receives: Radiation: Carotid ultrasound examination
30-39 year-old groupBased on the inclusion crtiteria, 200 healthy Han people at aged 30-39 and both sexes will be recruited in the analysis. Normal reference values of ultrafast pulse wave velocity will be obtained.
Receives: Radiation: Carotid ultrasound examination
40-49 year-old groupBased on the inclusion crtiteria, 200 healthy Han people at aged 40-49 and both sexes will be recruited in the analysis. Normal reference values of ultrafast pulse wave velocity will be obtained.
Receives: Radiation: Carotid ultrasound examination
50-59 year-old groupBased on the inclusion crtiteria, 200 healthy Han people at aged 50-59 and both sexes will be recruited in the analysis. Normal reference values of ultrafast pulse wave velocity will be obtained.
Receives: Radiation: Carotid ultrasound examination
60-69 year-old groupBased on the inclusion crtiteria, 200 healthy Han people at aged 60-69 and both sexes will be recruited in the analysis. Normal reference values of ultrafast pulse wave velocity will be obtained.
Receives: Radiation: Carotid ultrasound examination
70-79 year-old groupBased on the inclusion crtiteria, 200 healthy Han people at aged 70-79 and both sexes will be recruited in the analysis. Normal reference values of ultrafast pulse wave velocity will be obtained.
Receives: Radiation: Carotid ultrasound examination

What is being measured

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

  1. Carotid pulse wave velocity at the beginning and end of systole

    To establish the range of pulse wave velocity at the beginning of the systole (BS) and at the ending of the systole (ES) of normal carotid artery, and to identify the influencing factors for BS and ES in the carotid artery.

    Measured: 1 day

Secondary outcomes (2)

  1. Carotid artery intima-media thickness (IMT)

    IMT reflects the change of vascular wall structure, which is used to evaluate early atherosclerosis and .

    Measured: 1 day

  2. Serum biochemical index

    Serum laboratory testing for blood cholesterol level (total cholesterol, HDL (high-density lipoprotein), LDL (low-density lipoproteins), triglycerides), fasting blood-glucose will be examed.

    Measured: 1 day

Timeline

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

  1. First posted22 Nov 2017
  2. Study start1 Oct 2017
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2024 (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-control
Time perspective
Prospective
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03351127
Sponsor's protocol ID
ShengjingH-RWD
Status last verified
May 2020
First submitted
20 Nov 2017
Last updated
29 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Artery Diseases and Healthy Volunteers, run by Shengjing Hospital at 44 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 10 inclusion and 13 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 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Carotid pulse wave velocity at the beginning and end of systole (time frame: 1 day). 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 NCT03351127.

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 29 May 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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