Multicenter Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV)
The Multi-center Normal Reference Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Chinese Han Adults (CAR-PWV Study）
1 other identifier
observational
1,200
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 29, 2020
May 1, 2020
2.2 years
November 20, 2017
May 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Carotid pulse wave velocity at the beginning and end of systole
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.
1 day
Secondary Outcomes (2)
Carotid artery intima-media thickness (IMT)
1 day
Serum biochemical index
1 day
Study Arms (6)
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.
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.
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.
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.
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.
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.
Interventions
Carotid pulse wave velocity of all participants were measured by ultrafast ultrasound imaging technology using SuperSonic Imagine's Aixplorer ultrasound system.
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shengjing Hospitallead
- SuperSonic Imaginecollaborator
Study Sites (44)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Civil Aviation General Hospital
Beijing, Beijing Municipality, China
University-Town Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 401331, China
Central Hospital of Chongqing Three Gorges
Chongqing, Chongqing Municipality, 404000, China
Guangdong Second Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, 510405, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 518034, 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, 450000, 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, 050000, 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, 150001, 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, 430063, 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, 213003, 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, 330006, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Dalian Municipal Central Hospital
Dalian, Liaoning, 116033, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, 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, 610072, 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, 310007, China
Ningbo First Hospital
Ningbo, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weidong Ren
Shengjing Hospital of China Medical Univeristy
- PRINCIPAL INVESTIGATOR
Lixue Yin
People's Hospital of Sichuan Province
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Ultrasonic Department
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 22, 2017
Study Start
October 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2024
Last Updated
May 29, 2020
Record last verified: 2020-05