Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries

Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries: In Relation to Arterial Stiffness and Cardiovascular Risk Factors.

Background:

Augmented Velocity Index (Avi) is a new Doppler index which can potentially be used to assess arterial stiffness. The Avi of common carotid artery is found to be associated with arterial stiffness and have initial correlation with cardiovascular risk factors. Avi can be used in any vessels (superficial or deep vessels) where arterial Doppler waveforms can be obtained.

Aims:

The aims of this study are to investigate the associations of Avi of hepatic artery, renal artery, central retinal artery and internal carotid artery with arterial stiffness and cardiovascular risk factors in a group of apparently normal subjects.

Methods:

Recruit 350 subjects with no known medical illness or drug treatment for ultrasound examinations and blood tests. In ultrasound examination, the Avi of carotid arteries, hepatic arteries, renal arteries and retinal arteries are recorded. The carotid-femoral pulse wave velocity is also calculated for the assessment of central aortic stiffness.

Other important correlates of arterial stiffness including carotid intima-media thickness, fatty liver status, liver stiffness and abdominal fat thickness are assessed in the ultrasound examination.

The clinical and laboratory examinations include anthropometric indexes, plasma glucose level, lipid profile, renal function tests, liver function test, urinary albumin creatinine ratio, blood pressure measurement.

Study Overview

• Status: Not yet recruiting
• Conditions: Arterial Stiffness
• Intervention / Treatment: Diagnostic test: Ultrasound derived Avi

• Study Type: Observational
• Enrollment (Anticipated): 350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Apparently healthy volunteers

Description

Inclusion Criteria:

• Apparently healthy volunteers

Exclusion Criteria:

• Subjects with known medical illnesses including cancer, stroke, cardiovascular disease, diabetes, hypertension, dyslipidaemia, peripheral vascular disease, gout, systemic lupus erythematosus, psoriasis, rheumatoid arthritis and thyrotoxicosis.
• Subjects with long term drug use

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Augmented Velocity Index (Avi)	Avi of carotid, renal, hepatic and retinal arteries as recorded from the Doppler ultrasound waveforms of those arteries	Aug 2022 - May 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial wall thickness, liver stiffness and fatty liver status	Intima-media thickness of carotid artery is measured in gray scale ultrasound images; Liver stiffness is assessed by shear wave elastography of ultrasound technique; Fatty liver status is determined by the attenuation imaging of ultrasound	Aug 2022 - May 2024

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022.3.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No