Clinical trial NCT03351127: Multicenter Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV)
Official title: The Multi-center Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Chinese Han Adults (CAR-PWV Study）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Diseases
Healthy Volunteers
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: SuperSonic Imagine
First posted: 2017-11-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Carotid pulse wave velocity at the beginning and end of systole
timeFrame: 1 day
Secondary outcomes:
measure: Carotid artery intima-media thickness (IMT)
timeFrame: 1 day
measure: Serum biochemical index
timeFrame: 1 day
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Civil Aviation General Hospital
state: Beijing
city: Chongqing
country: China
facility: University-Town Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Central Hospital of Chongqing Three Gorges
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong Second Traditional Chinese Medicine Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: First Affiliated Hospital, Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of He'nan University of Science and Technology
state: Henan
city: Pingdingshan
country: China
facility: The First People's Hospital of Pingdingshan of He'nan Province
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Tumor Hospital Affiliated to He'nan University
state: Henan
city: Zhengzhou
country: China
facility: He'nan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuchang Hospital of Hubei Province
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial Geriatric Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Central Hospital
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Central Hospital Affiliated to Shenyang Medical College
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Yan'an
country: China
facility: Yan'an University Affiliated Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
state: Sichuan
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Ürümqi
country: China
facility: The First Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: The Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
state: Xinjiang
city: Hangzhou
country: China
facility: Hangzhou Hospital of Traditional Chinese Medicine
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
affiliation: Shengjing Hospital of China Medical Univeristy
name: Weidong Ren
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Sichuan Province
name: Lixue Yin
role: PRINCIPAL_INVESTIGATOR
References: