Multicenter Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV)
- Conditions
- Healthy VolunteersCarotid Artery Diseases
- Interventions
- Radiation: Carotid ultrasound examination
- Registration Number
- NCT03351127
- Lead Sponsor
- Shengjing Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 60-69 year-old group Carotid ultrasound examination 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. 30-39 year-old group Carotid ultrasound examination 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. 40-49 year-old group Carotid ultrasound examination 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. 18-29 year-old group Carotid ultrasound examination 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. 70-79 year-old group Carotid ultrasound examination 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. 50-59 year-old group Carotid ultrasound examination 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.
- Primary Outcome Measures
Name Time Method Carotid pulse wave velocity at the beginning and end of systole 1 day 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.
- Secondary Outcome Measures
Name Time Method Carotid artery intima-media thickness (IMT) 1 day IMT reflects the change of vascular wall structure, which is used to evaluate early atherosclerosis and .
Serum biochemical index 1 day Serum laboratory testing for blood cholesterol level (total cholesterol, HDL (high-density lipoprotein), LDL (low-density lipoproteins), triglycerides), fasting blood-glucose will be examed.
Trial Locations
- Locations (44)
University-Town Hospital of Chongqing Medical University
π¨π³Chongqing, Chongqing, China
Central Hospital of Chongqing Three Gorges
π¨π³Chongqing, Chongqing, China
The Second Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
The Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
π¨π³ΓrΓΌmqi, Xinjiang, China
Hangzhou Hospital of Traditional Chinese Medicine
π¨π³Hangzhou, Zhejiang, China
Guangdong Second Traditional Chinese Medicine Hospital
π¨π³Guangzhou, Guangdong, China
The First Affiliated Hospital of He'nan University of Science and Technology
π¨π³Luoyang, Henan, China
The First Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
π¨π³Guangzhou, Guangdong, China
Huadu District People's Hospital of Guangzhou
π¨π³Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Southern Medical University
π¨π³Guangzhou, Guangdong, China
Xinxiang Central Hospital
π¨π³Xinxiang, Henan, China
The First People's Hospital of Pingdingshan of He'nan Province
π¨π³Pingdingshan, Henan, China
Zhengzhou Tumor Hospital Affiliated to He'nan University
π¨π³Zhengzhou, Henan, China
He'nan Provincial People's Hospital
π¨π³Zhengzhou, Henan, China
The First People's Hospital of Changzhou
π¨π³Changzhou, Jiangsu, China
The Second Xiangya Hospital of Central South University
π¨π³Changsha, Hunan, China
The First Affiliated Hospital of Jinzhou Medical University
π¨π³Jinzhou, Liaoning, China
Jiangsu Province Hospital of Traditional Chinese Medicine
π¨π³Nanjing, Jiangsu, China
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
π¨π³Shenyang, Liaoning, China
The First Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
The Fourth Affiliated Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Shanxi Provincial People's Hospital
π¨π³Taiyuan, Shanxi, China
Yan'an University Affiliated Hospital
π¨π³Yan'an, Shanxi, China
Ningbo First Hospital
π¨π³Ningbo, Zhejiang, China
The First Affiliated Hospital of Bengbu Medical College
π¨π³Bengbu, Anhui, China
Civil Aviation General Hospital
π¨π³Beijing, Beijing, China
The First Hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
The Third Hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
Hebei General Hospital
π¨π³Shijiazhuang, Hebei, China
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
π¨π³Harbin, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
Wuchang Hospital of Hubei Province
π¨π³Wuhan, Hubei, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Dalian Municipal Central Hospital
π¨π³Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
Shengjing Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Central Hospital Affiliated to Shenyang Medical College
π¨π³Shenyang, Liaoning, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
π¨π³Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
π¨π³Luzhou, Sichuan, China
The First Hospital of Xinjiang Medical University
π¨π³ΓrΓΌmqi, Xinjiang, China
The Central Hospital of Wuhan
π¨π³Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Jiangsu Provincial Geriatric Hospital
π¨π³Nanjing, Jiangsu, China