A Multicenter Study of Ultrafast Pulse Wave Velocity in Obese Chinese Han Adults

Carotid Artery Diseases Clinical Trial

Official title:

Multicenter Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Obese Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455099
• Other study ID #: CO-UFPWV-01
• Status: Recruiting
• Start date: September 14, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2022
• Source: First Hospital of China Medical University
• Contact: Chunyan Ma, Ph.D
• Phone: 13998816448
• Email: cmu1h_mcy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In recent years, with the change of people's lifestyle and dietary structure, overweight and obesity have become serious problems threatening public health. During 1975-2016, the worldwide prevalence of overweight and obesity increased year by year. By 2016, about 40% of adults were overweight and obese, of which 2.3% of men and 5.0% of women were severely obese (i.e. body mass index ≥ 35 kg/m²). The number of overweight and obese people in China is growing rapidly. Report on the Nutrition and Chronic Disease Status of Chinese Residents (2020 version) shows that over 50% Chinese obese adults have overweight and obesity. Overweight and obesity have become one of the most serious public health problems in China. Previous studies have found that overweight and obesity are often accompanied by abnormalities of blood glucose, blood pressure and blood lipids, leading to dysfunction of vascular endothelial cells and changes in the structure and function of vascular wall, which are closely related to atherosclerosis. Therefore, early detection of atherosclerosis and timely intervention measures can effectively prevent and reduce the occurrence and development of atherosclerosis. At present, carotid intima-media thickness (CIMT) can be clinically used to evaluate carotid atherosclerosis, which can evaluate the morphological changes of carotid artery, but it cannot be used to evaluate the stiffness of carotid artery. PWV is the gold standard for evaluating arterial stiffness. However, the conventional PWV measurement method can evaluate the stiffness of long-distance artery. Evaluated outcomes are affected by height and body mass, and therefore, the evaluation accuracy of PWV can be limited. UFPWV is a novel noninvasive method developed in recent years to evaluate PWV. It can be used to evaluate PWV of local artery. Different from the conventional PWV method, UFPWV has a very high frame rate, up to 2000 frames/s, and can track the movement of arterial wall at specific segments in real time. UFPWV can obtain PWV at the beginning and end of systole by tracking and automatic analysis. In recent years, increasing attention has been paid to the role of UFPWV in the evaluation of carotid artery. UFPWV has been used in the study of carotid arteries in normal people, vascular Ehlers-Danlos syndrome, hypertension, hyperlipidemia, diabetes and other groups. In the early stage, First Hospital of China Medical University participated in the national multi- center, large-sample trial: multi-center study on normal value of ultrafast pulse wave velocity in Chinese Han adults. The center has accumulated rich experience during the project implementation. The center determined the normal reference value of UFPWV for Chinese Han adults and verified that UFPWV has good measurement repeatability. At the same time, the project team had applied UFPWV technology to study early carotid atherosclerosis in patients with metabolic syndrome and coronary slow flow phenomenon. The results show that UFPWV has been accelerated without marked thickening of CIMT, which preliminarily proves that UFPWV can accurately and sensitively detect early carotid atherosclerosis. This study aims to evaluate the feasibility of UFPWV in carotid stiffness of overweight and obese people, and correlate overweight/obesity with subclinical atherosclerosis, so as to provide an important theoretical basis for early monitoring and risk assessment of carotid atherosclerosis in overweight/obese people.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: July 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carotid Artery Diseases

Intervention

Radiation:
• Carotid ultrasound examination 1
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.
• Carotid ultrasound examination 2
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.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	Dalian Municipal Central Hospital	Dalian	Liaoning
China	Gejiu People's Hospital	Gejiu	Yunnan
China	Yuechi People's Hospital	Guang'an	Sichuan
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	the First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	People's Hospital of Leshan	Leshan	Sichuan
China	Jiangyou People's Hospital	Mianyang	Sichuan
China	Affiliated Hospital of Nanjing University of Chinese Medicine	Nanjing	Jiangsu
China	Jiangsu Province Official Hospital	Nanjing	Jiangsu
China	Affiliated Central Hospital of Shenyang Medical College	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Hebei General Hospital	Shijiazhuang	Hebei
China	the First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	NHC Key Laboratory of Hormones and Development, CHU Hsien-i Memorial Hospital and Tianjin Institute of Endocrinology	Tianjin	Tianjin
China	Xi'an Daxing Hospital	Xi'an	Shaanxi
China	Xiangyang No.1 Peoples Hospital	Xiangyang	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pulse wave velocity(m/s)at the beginning of the systole (BS) of carotid artery	To evaluate the pulse wave velocity(m/s)at the beginning of the systole (BS) of carotid artery in overweight/obese population	1 day after admission
Secondary	Carotid artery intima-media thickness (IMT)	IMT(mm) reflects the change of vascular wall structure, which is used to evaluate early atherosclerosis.	1 day after admission
Secondary	Serum biochemical index	Serum laboratory testing for blood total cholesterol level in mmol/L, high-density lipoprotein level in mmol/L, low-density lipoproteins level in mmol/L, triglycerides level in mmol/L, and fasting blood-glucose level in mmol/L will be examen.	1 day after admission