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临床试验/NCT05970926
NCT05970926尚未招募不适用

Normal Reference Values in Han Adults of Extremity Arterial Structure and Hemodynamics by High-frequency Ultrasound: a Multi-center Study in China

First Hospital of China Medical University0 个研究点目标入组 540 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
540
主要终点
Intima thickness of dorsalis pedis artery and proper palmar digital artery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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;
  • 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.

结局指标

主要结局

Intima thickness of dorsalis pedis artery and proper palmar digital artery

时间窗: 1 day

Intima thickness reflects the changes of vascular wall structure and is used for early evaluation of arterial disease.

次要结局

  • Blood flow velocity of dorsalis pedis artery and proper palmar digital artery(1 day)

研究者

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunyan Ma

Chief of Cardiovascular Ultrasound

First Hospital of China Medical University

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