Arterial StiffnessNCT05273905
Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries
An observational study of Arterial Stiffness, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- Ultrasound derived Avi
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Apparently healthy volunteers
Who may be able to join
- Apparently healthy volunteers
Who cannot join
- 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
About this study
Official title: 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.
Read more
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.
- Conditions
- Arterial Stiffness
- Being tested
- Ultrasound derived Avi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound derived AviDiagnostic test
Assess the Avi of carotid arteries, hepatic arteries, renal arteries and central retinal arteries.
What is being measured
The primary outcome is the main question the study is designed to answer.
Augmented Velocity Index (Avi)
Avi of carotid, renal, hepatic and retinal arteries as recorded from the Doppler ultrasound waveforms of those arteries
Measured: Aug 2022 - May 2024
Secondary outcomes (1)
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
Measured: Aug 2022 - May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study startMay 2022 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Kin Hung, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273905
- Sponsor's protocol ID
- 2022.3.1
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Velocity Index of Intra-abdominal, Carotid and Retinal Arteries: In Relation to Arterial Stiffness and Cardiovascular Risk Factors.
- ClinicalTrials.gov ID
- NCT05273905
- Acronym / sponsor ID
- 2022.3.1
- Conditions
- Arterial Stiffness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Apparently healthy volunteers
Key inclusion criteria (1 listed)
- Apparently healthy volunteers
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound derived AviAssess the Avi of carotid arteries, hepatic arteries, renal arteries and central retinal arteries. | Diagnostic test | – |
Primary outcome
Augmented Velocity Index (Avi)
Time frame: Aug 2022 - May 2024
Avi of carotid, renal, hepatic and retinal arteries as recorded from the Doppler ultrasound waveforms of those arteries
1 secondary outcome
Arterial wall thickness, liver stiffness and fatty liver status
Time frame: Aug 2022 - May 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Augmented Velocity Index (Avi) (time frame: Aug 2022 - May 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.