A Multicenter Study of Ultrafast Pulse Wave Velocity in Obese Chinese Han Adults
Multicenter Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Obese Adults
1 other identifier
observational
2,400
1 country
22
Brief Summary
Ultrafast pulse wave velocity (UFPWV) is a novel non-invasive method developed recently to evaluate pulse wave velocity (PWV). This multi-center clinical trial aims to evaluate the feasibility of UFPWV in the evaluation of the carotid stiffness of overweight and obese population and investigate the correlation between overweight/obesity and subclinical atherosclerosis, providing an important theoretical basis for early monitoring and risk assessment of carotid atherosclerosis in overweight/obese people.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
22 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
First Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedOctober 12, 2022
October 1, 2022
12 months
July 6, 2022
October 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulse wave velocity（m/s）at the ending of the systole (ES) of carotid artery
To evaluate the pulse wave velocity（m/s）at the ending of the systole (ES) of carotid artery in overweight/obese population.
1 day after admission
Secondary Outcomes (3)
Pulse wave velocity（m/s）at the beginning of the systole (BS) of carotid artery
1 day after admission
Carotid artery intima-media thickness (IMT)
1 day after admission
Serum biochemical index
1 day after admission
Study Arms (2)
obese group
Participants will be assigned to obese group (body mass index 24.0-27.9 kg/m²). Based on the inclusion criteria, 1200 overweight Han people（body mass index 24.0-27.9 kg/m²）and both sexes will be recruited in the analysis. The values of ultrafast pulse wave velocity will be obtained.
overweight group
Participants will be assigned to overweight group (body mass index ≥ 28.0 kg/m²). Based on the inclusion criteria, 1200 obese Han people（body mass index ≥28.0 kg/m²） and both sexes will be recruited in the analysis. The values of ultrafast pulse wave velocity will be obtained.
Interventions
Participants will be assigned to obese group (body mass index 24.0-27.9 kg/m²). Carotid pulse wave velocity of all participants were measured by ultrafast ultrasound imaging technology using SuperSonic Imagine's explorer ultrasound system.
Based on the inclusion criteria, 1200 overweight Han people（body mass index ≥28.0 kg/m²） and both sexes will be recruited in the analysis. The values of ultrafast pulse wave velocity will be obtained.
Eligibility Criteria
Study population description \* (only for observational study): 2400 overweight or obese adults will be recruited from physical examination center. They will be assigned to overweight group (body mass index 24.0-27.9 kg/m²; n = 1200) and obese group (body mass index ≥ 28.0 kg/m²; n = 1200).
You may qualify if:
- Han nationality;
- Age ≥18 - 80 years;
- Body mass index ≥ 24 kg/m²;
- Blood pressure ≥ 90/60 mmHg (1 mmHg = 0.133 kPa);
- Fasting blood glucose level ≥ 3.9 mmol/L;
- No abnormality in cardiovascular and respiratory system found by physical examination;
- Normal findings in routine blood test, routine urine test, liver function and kidney function;
- No history of cardiovascular disease, respiratory system disease, liver and kidney disease except hypertension, diabetes or hyperlipidemia;
- Electrocardiogram examination showed no arrhythmia or myocardial infarction;
- No structural cardiac abnormalities (such as moderate or above cardiac valve regurgitation, abnormal ventricular wall motion, congenital heart disease, cardiomyopathy, pericardial lesions) were found by echocardiography, and left ventricular ejection fraction ≥ 53%;
- No marked abnormality in ultrasonography of the liver, gallbladder, pancreas, spleen and kidney;
- Normal findings in carotid ultrasound examination.
You may not qualify if:
- Hepatorenal insufficiency;
- Respiratory diseases: Acute or chronic respiratory diseases;
- Large artery diseases: aortic dilatation, aortic dissection, aortic coarctation, multiple Takayasu arteritis, etc;
- Special diseases: history of malignant tumor, acute or chronic infection, moderate to severe anemia, disability or mental disorder, autoimmune diseases, acquired immunodeficiency syndrome, etc;
- Pregnant or lactating women;
- Recent history of surgery and trauma;
- Organ transplant;
- Poor ultrasonic image quality, which cannot meet analysis requirement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Beijing Hospital
Beijing, Beijing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Guangdong Province Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
the Fifth Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hebei General Hospital
Shijiazhuang, Hebei, China
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Xiangyang No.1 Peoples Hospital
Xiangyang, Hubei, China
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Jiangsu Province Official Hospital
Nanjing, Jiangsu, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
the First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Affiliated Central Hospital of Shenyang Medical College
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Xi'an Daxing Hospital
Xi'an, Shaanxi, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Yuechi People's Hospital
Guang’an, Sichuan, China
People's Hospital of Leshan
Leshan, Sichuan, China
Jiangyou People's Hospital
Mianyang, Sichuan, China
NHC Key Laboratory of Hormones and Development, CHU Hsien-i Memorial Hospital and Tianjin Institute of Endocrinology
Tianjin, Tianjin Municipality, China
Gejiu People's Hospital
Gejiu, Yunnan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunyan Ma, Ph.D
the First Hospital of China Medical Univeristy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Cardiovascular Ultrasound
Study Record Dates
First Submitted
July 6, 2022
First Posted
July 13, 2022
Study Start
September 14, 2022
Primary Completion
August 31, 2023
Study Completion
July 31, 2024
Last Updated
October 12, 2022
Record last verified: 2022-10