NCT05273905

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

March 1, 2022

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Arterial wall thickness, liver stiffness and fatty liver status

    Aug 2022 - May 2024

Interventions

Ultrasound derived AviDIAGNOSTIC_TEST

Assess the Avi of carotid arteries, hepatic arteries, renal arteries and central retinal arteries.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Apparently healthy volunteers

You may qualify if:

  • Apparently healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor

Study Record Dates

First Submitted

March 1, 2022

First Posted

March 10, 2022

Study Start

May 1, 2022

Primary Completion

August 1, 2024

Study Completion

March 1, 2025

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share