A Multicenter Study of Ultrafast Pulse Wave Velocity in Obese Chinese Han Adults
NCT ID: NCT05455099
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
2400 participants
OBSERVATIONAL
2022-09-14
2024-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RF Based QIMT & QAS Study on Chinese Adults
NCT04881292
CT Evaluation of Cardiovascular Risk Markers in Obese Patients
NCT03111693
A Community-based Prospective Cohort Study on Metabolic Dysfunction-Associated Fatty Liver Disease in Older Adults: From Metabolic Trajectories to Extrahepatic Outcomes
NCT07241195
Clinical Classification and Imaging Markers in Patients of Obesity
NCT06649071
Alternation of Non-alcoholic Fatty Liver Disease (NAFLD) and Cardiovascular Risks After Liftestyle Modification: A Ultrasound Attenuation Imaging-Based Study
NCT04440540
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Hospital of China Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chunyan Ma
Chief of Cardiovascular Ultrasound
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chunyan Ma, Ph.D
Role: PRINCIPAL_INVESTIGATOR
the First Hospital of China Medical Univeristy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Weide Dai, Ph.D
Role: primary
Qiang Wu, Bachelor
Role: primary
Jianxing Zhang, Ph.D
Role: primary
Yuqing Chen, Master
Role: primary
Jianmin Qiu, Bachelor
Role: primary
Li Li, Ph.D
Role: primary
Yandong Deng, M.D
Role: primary
Jianjun Yuan, M.D
Role: primary
Yu Wang, Ph.D
Role: primary
Yiyun Wu, M.D
Role: primary
Xuezhong Jiang, M.D
Role: primary
Xiaofang Pan, M.D
Role: primary
Yuhong Li, Ph.D
Role: primary
Minghui Xiang, M.D
Role: primary
Weidong Ren, Ph.D
Role: primary
Jinzhuo Yue, M.D
Role: primary
Guanghe Cui, M.D
Role: primary
Cunjun Yin, Master
Role: primary
Ying Liu, M.D
Role: primary
Xiaodong Zhao, Master
Role: primary
Lei Gao, M.D
Role: primary
Jianwei Sun, Ph.D
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CO-UFPWV-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.