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

NCT ID: NCT03351127

Last Updated: 2020-05-29

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

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carotid Artery Diseases Healthy Volunteers

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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18-29 year-old group

Based 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.

Carotid ultrasound examination

Intervention Type RADIATION

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

30-39 year-old group

Based 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.

Carotid ultrasound examination

Intervention Type RADIATION

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

40-49 year-old group

Based 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.

Carotid ultrasound examination

Intervention Type RADIATION

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

50-59 year-old group

Based 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.

Carotid ultrasound examination

Intervention Type RADIATION

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

60-69 year-old group

Based 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.

Carotid ultrasound examination

Intervention Type RADIATION

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

70-79 year-old group

Based 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.

Carotid ultrasound examination

Intervention Type RADIATION

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

Interventions

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Carotid ultrasound examination

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SuperSonic Imagine

INDUSTRY

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weidong Ren

Director of Ultrasonic Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weidong Ren

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital of China Medical Univeristy

Lixue Yin

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Sichuan Province

Locations

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status

Civil Aviation General Hospital

Beijing, Beijing Municipality, China

Site Status

University-Town Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Central Hospital of Chongqing Three Gorges

Chongqing, Chongqing Municipality, China

Site Status

Guangdong Second Traditional Chinese Medicine Hospital

Guangzhou, Guangdong, China

Site Status

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Huadu District People's Hospital of Guangzhou

Guangzhou, Guangdong, China

Site Status

The Fifth Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

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

Luoyang, He'nan, China

Site Status

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

Pingdingshan, He'nan, China

Site Status

Xinxiang Central Hospital

Xinxiang, He'nan, China

Site Status

Zhengzhou Tumor Hospital Affiliated to He'nan University

Zhengzhou, He'nan, China

Site Status

He'nan Provincial People's Hospital

Zhengzhou, He'nan, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, He'nan, China

Site Status

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, He'nan, China

Site Status

Hebei General Hospital

Shijiazhuang, Hebei, China

Site Status

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, Hu'nan, China

Site Status

Wuchang Hospital of Hubei Province

Wuhan, Hubei, China

Site Status

The Central Hospital of Wuhan

Wuhan, Hubei, China

Site Status

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

Wuhan, Hubei, China

Site Status

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Site Status

Jiangsu Province Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Site Status

Jiangsu Provincial Geriatric Hospital

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status

Dalian Municipal Central Hospital

Dalian, Liaoning, China

Site Status

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China

Site Status

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

Site Status

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Site Status

Yan'an University Affiliated Hospital

Yan’an, Shanxi, China

Site Status

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

Chengdu, Sichuan, China

Site Status

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Site Status

The First Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

The Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang, China

Site Status

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, Zhejiang, China

Site Status

Ningbo First Hospital

Ningbo, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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ShengjingH-RWD

Identifier Type: -

Identifier Source: org_study_id

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