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

NCT05970926 | Unknown DMC

• 1 other identifier: NOVAEA-HFUS-01
• Study Type: observational
• Target: 540
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteer; Artery Disease

Keywords

extremity arterial structure; extremity arterial blood flow; high-frequency ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (1)

• Blood flow velocity of dorsalis pedis artery and proper palmar digital artery

  1 day

Interventions

high-frequency ultrasound DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese healthy Han adults

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Officials

• Lixin Jiang, PHD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Xinhua Ye, PHD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• WeiDong Ren, PHD

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Xin Guan, PHD

  Tianjin Chest Hospital

  PRINCIPAL INVESTIGATOR

• Hongning Yin, PHD

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Xiaoshan Zhang, PHD

  The Affiliated Hospital of Inner Mongolia Medical University

  PRINCIPAL INVESTIGATOR

• Yuhong Zhang, PHD

  The Second Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Qingxiong Yue, PHD

  Dalian Municipal Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyan Ma, PHD

CONTACT

13998816448; cmu1h_mcy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiovascular Ultrasound

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 1, 2023
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share