Multicenter Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV)
NCT ID: NCT03351127
Last Updated: 2020-05-29
Study Results
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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UNKNOWN
1200 participants
OBSERVATIONAL
2017-10-01
2024-12-31
Brief Summary
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Detailed Description
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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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Study Design
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CASE_CONTROL
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
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
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
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
79 Years
ALL
Yes
Sponsors
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SuperSonic Imagine
INDUSTRY
Shengjing Hospital
OTHER
Responsible Party
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Weidong Ren
Director of Ultrasonic Department
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
Civil Aviation General Hospital
Beijing, Beijing Municipality, China
University-Town Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Central Hospital of Chongqing Three Gorges
Chongqing, Chongqing Municipality, China
Guangdong Second Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of He'nan University of Science and Technology
Luoyang, He'nan, China
The First People's Hospital of Pingdingshan of He'nan Province
Pingdingshan, He'nan, China
Xinxiang Central Hospital
Xinxiang, He'nan, China
Zhengzhou Tumor Hospital Affiliated to He'nan University
Zhengzhou, He'nan, China
He'nan Provincial People's Hospital
Zhengzhou, He'nan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, He'nan, 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
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
Changsha, Hu'nan, China
Wuchang Hospital of Hubei Province
Wuhan, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Jiangsu Provincial Geriatric Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Central Hospital Affiliated to Shenyang Medical College
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
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Yan'an University Affiliated Hospital
Yan’an, Shanxi, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Ürümqi, Xinjiang, China
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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ShengjingH-RWD
Identifier Type: -
Identifier Source: org_study_id
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