Healthy VolunteerNOVAEA-HFUSNCT05970926
Normal Reference Values in Han Adults of Extremity Arterial Structure and Hemodynamics by High-frequency Ultrasound
An observational study of Healthy Volunteer and Artery Disease, run by First Hospital of China Medical University.
Trial summary
In recent years, high-frequency ultrasound, due to its higher resolution, can clearly display the superficial vascular structure and blood flow, and can detect vascular lesions early, providing a new non-invasive tool for clinical observation of the structure and blood flow of the extremity artery. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Artery Disease
- What is being tested?
- high-frequency ultrasound
- Type of treatment
- Medical device
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Aug 2025
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese healthy Han adults
Who may be able to join
- Han nationality;
- Ages 18-79;
- Normal blood pressure (139-90/89-60mmHg);
- Body mass index < 30 kg/m2;
- Blood routine, fasting blood glucose, blood lipid, liver and kidney function, electrocardiogram were normal;
- No history of cyanosis of hands and feet, cold stimulation without discomfort, no Raynaud phenomenon has occurred in all parts of the body;
- No cardiovascular disease, diabetes, rheumatic connective tissue disease, serious liver and kidney dysfunction;
- No history of drug use affecting cardiovascular system.
Who cannot join
- Patients with hypertension, diabetes, hyperthyroidism, arrhythmia and other diseases;
- Patients with systemic lupus erythematosus, polymyositis, rheumatoid arthritis and other connective tissue diseases;
- A history of related blood diseases;
- Have taken vasoconstrictor drugs in the past 1 month;
- Gangrene of fingers and toes or history of trauma or surgery;
- Have a history of handicraft, hammering, digging and other related work;
Show all 9Show fewer
- Have a long history of smoking and drinking;
- Peripheral vascular disease, arterial occlusion can not detect blood flow signal;
- Unable to cooperate with the examiner.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Normal Reference Values in Han Adults of Extremity Arterial Structure and Hemodynamics by High-frequency Ultrasound: a Multi-center Study in China
In recent years, high-frequency ultrasound, due to its higher resolution, can clearly display the superficial vascular structure and blood flow, and can detect vascular lesions early, providing a new non-invasive tool for clinical observation of the structure and blood flow of the extremity artery. The purpose of this multi-center study is to establish the normal value of high frequency ultrasound for the structure and blood flow of the extremity arteries of Chinese Han adults, and to explore the influencing factors, so as to provide a quantitative reference for the early diagnosis, degree evaluation and curative effect observation of the structure and blood flow of the extremities.
Read the detailed description
The extremity artery is the peripheral blood vessel of the whole body, and it is often involved early in the diseases that are easy to damage the small vessels, such as atherosclerosis and connective tissue diseases. Early lower limb atherosclerosis mainly occurs in the dorsal foot artery, which is commonly seen in people with diabetes and long-term smoking. Connective tissue diseases such as systemic sclerosis and systemic lupus erythematosus also mainly involve small blood vessels, and vascular lesions may appear earlier than those of other specific organs such as heart and lung. Because of its shallow location, the extremity artery can be better used as a screening site for vascular diseases, and it is the window for early reaction of vascular diseases.However, the early stage of extremity artery disease is easy to be ignored, and patients often have pain and numbness of the affected limb. When the disease is severe, it can lead to ulcer not healing, and even limb gangrene and amputation, which greatly affects the quality of life and brings huge troubles and economic pressure to the patients. Therefore, early diagnosis of extremity arterial lesions is of great significance for early diagnosis of microvascular injury diseases such as atherosclerosis and connective tissue diseases, reducing the incidence of complications, and reducing the rate of amputation and mortality.
Ultrasound is a non-invasive imaging technique widely used in clinic. In recent years, with the development of ultrasound technology, the frequency of ultrasonic probes has been increasing. Because of its higher resolution, high-frequency ultrasound can clearly display the superficial vascular structure and blood flow, detect vascular lesions early, and accurately quantify the degree of stenosis, providing a new and beneficial tool for clinical observation of the structure and blood flow of the extremity artery. The purpose of this multi-center clinical study was to establish the normal value of high frequency ultrasound for the structure and blood flow of the extremities of Chinese Han adults, and to explore its influencing factors, so as to provide a quantitative reference for the early diagnosis, degree evaluation and curative effect observation of the structure and blood flow of the extremities.
- Conditions
- Healthy Volunteer, Artery Disease
- Being tested
- high-frequency ultrasound
- Keywords
- extremity arterial structure, extremity arterial blood flow, high-frequency ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-frequency ultrasoundDevice
The volunteers will be given a high-frequency ultrasound examination of the extremity arteries, which is non-invasive, and the parameters of arterial structure and blood flow will be measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima thickness of dorsalis pedis artery and proper palmar digital artery
Intima thickness reflects the changes of vascular wall structure and is used for early evaluation of arterial disease.
Measured: 1 day
Secondary outcomes (1)
Blood flow velocity of dorsalis pedis artery and proper palmar digital artery
Blood flow velocity reflects hemodynamic changes and is used for early evaluation of arterial disease.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 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
- Lixin Jiang, PHD, Principal investigator, Shanghai Jiao Tong University School of MedicineXinhua Ye, PHD, Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityWeiDong Ren, PHD, Principal investigator, Shengjing HospitalXin Guan, PHD, Principal investigator, Tianjin Chest HospitalHongning Yin, PHD, Principal investigator, The Second Hospital of Hebei Medical UniversityXiaoshan Zhang, PHD, Principal investigator, The Affiliated Hospital of Inner Mongolia Medical UniversityYuhong Zhang, PHD, Principal investigator, The Second Affiliated Hospital of Dalian Medical UniversityQingxiong Yue, PHD, Principal investigator, Dalian Municipal Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970926
- Sponsor's protocol ID
- NOVAEA-HFUS-01
- Acronym
- NOVAEA-HFUS
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Reference Values in Han Adults of Extremity Arterial Structure and Hemodynamics by High-frequency Ultrasound: a Multi-center Study in China
- ClinicalTrials.gov ID
- NCT05970926
- Acronym / sponsor ID
- NOVAEA-HFUS / NOVAEA-HFUS-01
- Conditions
- Healthy Volunteer, Artery Disease
- Keywords
- extremity arterial structure, extremity arterial blood flow, high-frequency ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 1 Aug 2023 (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.
In recent years, high-frequency ultrasound, due to its higher resolution, can clearly display the superficial vascular structure and blood flow, and can detect vascular lesions early, providing a new non-invasive tool for clinical observation of the structure and blood flow of the extremity artery. The purpose of this multi-center study is to establish the normal value of high frequency ultrasound for the structure and blood flow of the extremity arteries of Chinese Han adults, and to explore the influencing factors, so as to provide a quantitative reference for the early diagnosis, degree evaluation and curative effect observation of the structure and blood flow of the extremities.
Detailed description
The extremity artery is the peripheral blood vessel of the whole body, and it is often involved early in the diseases that are easy to damage the small vessels, such as atherosclerosis and connective tissue diseases. Early lower limb atherosclerosis mainly occurs in the dorsal foot artery, which is commonly seen in people with diabetes and long-term smoking. Connective tissue diseases such as systemic sclerosis and systemic lupus erythematosus also mainly involve small blood vessels, and vascular lesions may appear earlier than those of other specific organs such as heart and lung. Because of its shallow location, the extremity artery can be better used as a screening site for vascular diseases, and it is the window for early reaction of vascular diseases.However, the early stage of extremity artery disease is easy to be ignored, and patients often have pain and numbness of the affected limb. When the disease is severe, it can lead to ulcer not healing, and even limb gangrene and amputation, which greatly affects the quality of life and brings huge troubles and economic pressure to the patients. Therefore, early diagnosis of extremity arterial lesions is of great significance for early diagnosis of microvascular injury diseases such as atherosclerosis and connective tissue diseases, reducing the incidence of complications, and reducing the rate of amputation and mortality.
Ultrasound is a non-invasive imaging technique widely used in clinic. In recent years, with the development of ultrasound technology, the frequency of ultrasonic probes has been increasing. Because of its higher resolution, high-frequency ultrasound can clearly display the superficial vascular structure and blood flow, detect vascular lesions early, and accurately quantify the degree of stenosis, providing a new and beneficial tool for clinical observation of the structure and blood flow of the extremity artery. The purpose of this multi-center clinical study was to establish the normal value of high frequency ultrasound for the structure and blood flow of the extremities of Chinese Han adults, and to explore its influencing factors, so as to provide a quantitative reference for the early diagnosis, degree evaluation and curative effect observation of the structure and blood flow of the extremities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese healthy Han adults
Key inclusion criteria (8 listed)
- Han nationality;
- Ages 18-79;
- Normal blood pressure (139-90/89-60mmHg);
- Body mass index < 30 kg/m2;
- Blood routine, fasting blood glucose, blood lipid, liver and kidney function, electrocardiogram were normal;
Key exclusion criteria (9 listed)
- Patients with hypertension, diabetes, hyperthyroidism, arrhythmia and other diseases;
- Patients with systemic lupus erythematosus, polymyositis, rheumatoid arthritis and other connective tissue diseases;
- A history of related blood diseases;
- Have taken vasoconstrictor drugs in the past 1 month;
- Gangrene of fingers and toes or history of trauma or surgery;
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 |
|---|---|---|
| high-frequency ultrasoundThe volunteers will be given a high-frequency ultrasound examination of the extremity arteries, which is non-invasive, and the parameters of arterial structure and blood flow will be measured. | Device | – |
Primary outcome
Intima thickness of dorsalis pedis artery and proper palmar digital artery
Time frame: 1 day
Intima thickness reflects the changes of vascular wall structure and is used for early evaluation of arterial disease.
1 secondary outcome
Blood flow velocity of dorsalis pedis artery and proper palmar digital artery
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Lixin Jiang, PHD principal investigator
Shanghai Jiao Tong University School of Medicine
Xinhua Ye, PHD principal investigator
The First Affiliated Hospital with Nanjing Medical University
WeiDong Ren, PHD principal investigator
Shengjing Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Artery Disease, run by First Hospital of China Medical University.
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 8 inclusion and 9 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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, PHD (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?
Intima thickness of dorsalis pedis artery and proper palmar digital artery (time frame: 1 day). 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 1 Aug 2023.