Clincosm LogoSign in Get a demo

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

Sponsor
Shengjing Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03351127
Collaborator
SuperSonic Imagine (Industry)
1,200
Enrollment
44
Locations
87
Anticipated Duration (Months)
27.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Carotid ultrasound examination

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.

Study Design

Study Type:
Observational
Actual Enrollment :
1200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Multi-center Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Chinese Han Adults (CAR-PWV Study）
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Carotid artery intima-media thickness (IMT) [1 day]

    IMT reflects the change of vascular wall structure, which is used to evaluate early atherosclerosis and .

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233004
2 Civil Aviation General Hospital Beijing Beijing China
3 University-Town Hospital of Chongqing Medical University Chongqing Chongqing China 401331
4 Central Hospital of Chongqing Three Gorges Chongqing Chongqing China 404000
5 Guangdong Second Traditional Chinese Medicine Hospital Guangzhou Guangdong China 510405
6 Guangdong Provincial Hospital of Traditional Chinese Medicine Guangzhou Guangdong China 518034
7 Huadu District People's Hospital of Guangzhou Guangzhou Guangdong China
8 The Fifth Affiliated Hospital of Southern Medical University Guangzhou Guangdong China
9 Hebei General Hospital Shijiazhuang Hebei China 050000
10 The First Hospital of Hebei Medical University Shijiazhuang Hebei China
11 The Third Hospital of Hebei Medical University Shijiazhuang Hebei China
12 The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
13 First Affiliated Hospital, Heilongjiang University of Chinese Medicine Harbin Heilongjiang China
14 The First Affiliated Hospital of He'nan University of Science and Technology Luoyang Henan China
15 The First People's Hospital of Pingdingshan of He'nan Province Pingdingshan Henan China
16 Xinxiang Central Hospital Xinxiang Henan China
17 Zhengzhou Tumor Hospital Affiliated to He'nan University Zhengzhou Henan China 450000
18 He'nan Provincial People's Hospital Zhengzhou Henan China
19 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
20 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
21 Wuchang Hospital of Hubei Province Wuhan Hubei China 430063
22 The Central Hospital of Wuhan Wuhan Hubei China
23 Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China
24 The Second Xiangya Hospital of Central South University Changsha Hunan China
25 The First People's Hospital of Changzhou Changzhou Jiangsu China 213003
26 Jiangsu Province Hospital of Traditional Chinese Medicine Nanjing Jiangsu China
27 Jiangsu Provincial Geriatric Hospital Nanjing Jiangsu China
28 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
29 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116011
30 Dalian Municipal Central Hospital Dalian Liaoning China 116033
31 The First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning China
32 Shengjing Hospital of China Medical University Shenyang Liaoning China 110004
33 Central Hospital Affiliated to Shenyang Medical College Shenyang Liaoning China
34 The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang Liaoning China
35 The First Hospital of China Medical University Shenyang Liaoning China
36 The Fourth Affiliated Hospital of China Medical University Shenyang Liaoning China
37 Shanxi Provincial People's Hospital Taiyuan Shanxi China
38 Yan'an University Affiliated Hospital Yan'an Shanxi China
39 Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital Chengdu Sichuan China 610072
40 The Affiliated Hospital of Southwest Medical University Luzhou Sichuan China
41 The First Hospital of Xinjiang Medical University Ürümqi Xinjiang China
42 The Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine Ürümqi Xinjiang China
43 Hangzhou Hospital of Traditional Chinese Medicine Hangzhou Zhejiang China 310007
44 Ningbo First Hospital Ningbo Zhejiang China

Sponsors and Collaborators

  • Shengjing Hospital
  • SuperSonic Imagine

Investigators

  • Principal Investigator: Weidong Ren, Shengjing Hospital of China Medical Univeristy
  • Principal Investigator: Lixue Yin, People's Hospital of Sichuan Province

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weidong Ren, Director of Ultrasonic Department, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT03351127
Other Study ID Numbers:
  • ShengjingH-RWD
First Posted:
Nov 22, 2017
Last Update Posted:
May 29, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carotid Artery Diseases

Study Results

No Results Posted as of May 29, 2020