Ignite Creation Date:
2024-05-06 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03351127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2020-05-29
First Post:
2017-11-20
Brief Title:
Multicenter Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity UFPWV
Sponsor:
Shengjing Hospital
Organization:
Shengjing Hospital
Study Overview
Official Title:
The Multi-center Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity UFPWV in Chinese Han Adults CAR-PWV Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To establish the range of BS and ES ms 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None