Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05970926 |
| Other study ID # |
NOVAEA-HFUS-01 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
August 31, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
First Hospital of China Medical University |
| Contact |
Chunyan Ma, PHD |
| Phone |
13998816448 |
| Email |
cmu1h_mcy[@]126.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
