Carotid Artery DiseasesNCT05455099
A Multicenter Study of Ultrafast Pulse Wave Velocity in Obese Chinese Han Adults
An observational study of Carotid Artery Diseases, run by First Hospital of China Medical University at 22 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Diseases
- What is being tested?
- Carotid ultrasound examination 1 and Carotid ultrasound examination 2
- Type of treatment
- Surgery or procedure
- How many people
- 2,400 participants
- Where
- 22 sitesChina
- Study dates
- 14 Sep 2022to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
Weide Dai, Ph.D
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong
Guanghe Cui, M.D
- Recruiting
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality
Qiang Wu, Bachelor
- Recruiting
Dalian Municipal Central Hospital
Dalian, Liaoning
Xiaofang Pan, M.D
- Recruiting
Gejiu People's Hospital
Gejiu, Yunnan
Jianwei Sun, Ph.D
- Recruiting
Yuechi People's Hospital
Guang’an, Sichuan
Cunjun Yin, Master
- Recruiting
Guangdong Province Hospital of Chinese Medicine
Guangzhou, Guangdong
Jianxing Zhang, Ph.D
- Recruiting
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong
Yuqing Chen, Master
- Recruiting
the Fifth Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
Jianmin Qiu, Bachelor
- Recruiting
the First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning
Yuhong Li, Ph.D
- Recruiting
People's Hospital of Leshan
Leshan, Sichuan
Ying Liu, M.D
- Recruiting
Jiangyou People's Hospital
Mianyang, Sichuan
Xiaodong Zhao, Master
- Recruiting
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu
Yiyun Wu, M.D
- Recruiting
Jiangsu Province Official Hospital
Nanjing, Jiangsu
Xuezhong Jiang, M.D
- Recruiting
Affiliated Central Hospital of Shenyang Medical College
Shenyang, Liaoning
Minghui Xiang, M.D
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Weidong Ren, Ph.D
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Li Li, Ph.D
- Recruiting
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Yandong Deng, M.D
- Recruiting
NHC Key Laboratory of Hormones and Development, CHU Hsien-i Memorial Hospital and Tianjin Institute of Endocrinology
Tianjin, Tianjin Municipality
Lei Gao, M.D
- Recruiting
Xi'an Daxing Hospital
Xi'an, Shaanxi
Jinzhuo Yue, M.D
- Recruiting
Xiangyang No.1 Peoples Hospital
Xiangyang, Hubei
Yu Wang, Ph.D
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Jianjun Yuan, M.D
About this study
Official title: Multicenter Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Obese Adults
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.
Read the detailed 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.
- Conditions
- Carotid Artery Diseases
- Being tested
- Carotid ultrasound examination 1, Carotid ultrasound examination 2
- Keywords
- Obesity, Pulse Wave Velocity, Carotid Artery Diseases, Cerebrovascular Disorders, Vascular Diseases, Cardiovascular Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Medical subject headings
- Carotid Artery Diseases, Obesity, Cerebrovascular Disorders, Vascular Diseases, Cardiovascular Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasound examination 1Radiation
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 2Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Carotid ultrasound examination 1 | |
| 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. Receives: Radiation: Carotid ultrasound examination 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day after admission
Secondary outcomes (3)
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
Measured: 1 day after admission
Carotid artery intima-media thickness (IMT)
IMT（mm） reflects the change of vascular wall structure, which is used to evaluate early atherosclerosis.
Measured: 1 day after admission
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.
Measured: 1 day after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start14 Sep 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Ma, First Hospital of China Medical University
- Investigators
- Chunyan Ma, Ph.D, Principal investigator, the First Hospital of China Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455099
- Sponsor's protocol ID
- CO-UFPWV-01
- Status last verified
- Oct 2022
- First submitted
- 6 Jul 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Carotid Artery Ultrafast Pulse Wave Velocity (UFPWV) in Obese Adults
- ClinicalTrials.gov ID
- NCT05455099
- Acronym / sponsor ID
- CO-UFPWV-01
- Conditions
- Carotid Artery Diseases
- Keywords
- Obesity, Pulse Wave Velocity, Carotid Artery Diseases, Cerebrovascular Disorders, Vascular Diseases, Cardiovascular Diseases, Brain Diseases, Central Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese group | – | Radiation: Carotid ultrasound examination 1Participants 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 | – | Radiation: Carotid ultrasound examination 2Participants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid ultrasound examination 1Participants 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. | Radiation | obese group |
| Carotid ultrasound examination 2Based 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. | Radiation | overweight group |
Primary outcome
Pulse wave velocity（m/s）at the ending of the systole (ES) of carotid artery
Time frame: 1 day after admission
To evaluate the pulse wave velocity（m/s）at the ending of the systole (ES) of carotid artery in overweight/obese population.
3 secondary outcomes
Pulse wave velocity（m/s）at the beginning of the systole (BS) of carotid artery
Time frame: 1 day after admission
Carotid artery intima-media thickness (IMT)
Time frame: 1 day after admission
Serum biochemical index
Time frame: 1 day after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunyan Ma, Ph.D principal investigator
the First Hospital of China Medical Univeristy
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases, run by First Hospital of China Medical University at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunyan Ma, Ph.D (13998816448, cmu1h_mcy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity（m/s）at the ending of the systole (ES) of carotid artery (time frame: 1 day after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.