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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03351127
• Other study ID #: ShengjingH-RWD
• Status: Active, not recruiting
• Start date: October 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2020
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
China	Civil Aviation General Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Central Hospital of Chongqing Three Gorges	Chongqing	Chongqing
China	University-Town Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dalian Municipal Central Hospital	Dalian	Liaoning
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Guangdong Second Traditional Chinese Medicine Hospital	Guangzhou	Guangdong
China	Huadu District People's Hospital of Guangzhou	Guangzhou	Guangdong
China	The Fifth Affiliated Hospital of Southern Medical University	Guangzhou	Guangdong
China	Hangzhou Hospital of Traditional Chinese Medicine	Hangzhou	Zhejiang
China	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	The First Affiliated Hospital of He'nan University of Science and Technology	Luoyang	Henan
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Jiangsu Provincial Geriatric Hospital	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	The First People's Hospital of Pingdingshan of He'nan Province	Pingdingshan	Henan
China	Central Hospital Affiliated to Shenyang Medical College	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	The First Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine	Ürümqi	Xinjiang
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Wuchang Hospital of Hubei Province	Wuhan	Hubei
China	Xinxiang Central Hospital	Xinxiang	Henan
China	Yan'an University Affiliated Hospital	Yan'an	Shanxi
China	He'nan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhengzhou Tumor Hospital Affiliated to He'nan University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Shengjing Hospital	SuperSonic Imagine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	Carotid artery intima-media thickness (IMT)	IMT reflects the change of vascular wall structure, which is used to evaluate early atherosclerosis and .	1 day
Secondary	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.	1 day