Normal Reference Values in Han Adults of Extremity Arterial Structure and Hemodynamics by High-frequency Ultrasound

NCT ID: NCT05970926

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-08-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

high-frequency ultrasound

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Han nationality;

2. Ages 18-79;

3. Normal blood pressure (139-90/89-60mmHg);

4. Body mass index < 30 kg/m2;

5. Blood routine, fasting blood glucose, blood lipid, liver and kidney function, electrocardiogram were normal;

6. No history of cyanosis of hands and feet, cold stimulation without discomfort, no Raynaud phenomenon has occurred in all parts of the body;

7. No cardiovascular disease, diabetes, rheumatic connective tissue disease, serious liver and kidney dysfunction;

8. No history of drug use affecting cardiovascular system.

Exclusion Criteria

1. Patients with hypertension, diabetes, hyperthyroidism, arrhythmia and other diseases;

2. Patients with systemic lupus erythematosus, polymyositis, rheumatoid arthritis and other connective tissue diseases;

3. A history of related blood diseases;

4. Have taken vasoconstrictor drugs in the past 1 month;

5. Gangrene of fingers and toes or history of trauma or surgery;

6. Have a history of handicraft, hammering, digging and other related work;

7. Have a long history of smoking and drinking;

8. Peripheral vascular disease, arterial occlusion can not detect blood flow signal;

9. Unable to cooperate with the examiner.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chunyan Ma

Chief of Cardiovascular Ultrasound

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lixin Jiang, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Xinhua Ye, PHD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

WeiDong Ren, PHD

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Xin Guan, PHD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Hongning Yin, PHD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Xiaoshan Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Inner Mongolia Medical University

Yuhong Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Dalian Medical University

Qingxiong Yue, PHD

Role: PRINCIPAL_INVESTIGATOR

Dalian Municipal Central Hospital

Central Contacts

Chunyan Ma, PHD

Role: CONTACT

cmu1h_mcy@126.com

13998816448

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NOVAEA-HFUS-01

Identifier Type: -

Identifier Source: org_study_id