Vascular EndotheliumNCT04897191
Healthy Age-dependent Reference Values for Microvascular Structure and Function
An observational study of Vascular Endothelium and Microvascular Circulation, run by University of Surrey at 1 site in United Kingdom.
Trial summary
The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. How healthy ageing affects the smallest blood vessels (microcirculation) and is not well understood. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Endothelium, Microvascular Circulation, Arterial Stiffness
- What is being tested?
- Age
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2021to Aug 2021
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults aiming at n=10 of each decade
Who may be able to join
- Healthy, 20-70 years, BMI 20-30 kg/m^2
Who cannot join
- Diabetes mellitus, symptoms of acute infection, cardiac arrhythmias, active malignancy, clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication, active vasoactive medication.
Trial locations and contacts
1 site in 1 country.
Danuta Sampson, Dr. contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Surrey
Guildford, GU2 7XH
Mariam Bapir, m.bapir@surrey.ac.uk
About this study
Official title: Assessing Age-dependent Reference Values for Microvascular Structure and Function in Healthy Participant Together With Macrovascular Function With Optical Coherence Tomography Angiography
The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. How healthy ageing affects the smallest blood vessels (microcirculation) and is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation. We have developed an automated software (OCTAVA) to determine metrics to characterise the microcirculation on the layers of density, diameter and tortuosity.
In the current study we aim at providing reference values of these metrics in hands and feet of healthy people according to age together with macrovascular function in arms and legs.
- Being tested
- Age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgeOther
Determination of age-dependence
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy people age 20-70 years Receives: Other: Age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular density
Density of skin microvasculature of hand and foot with OCTA at rest and after 5 min distal occlusion
Measured: 1 day (One timepoint during single visit)
Microvascular diameter
Diameter of skin microvasculature of hand and foot with OCTA at rest and after 5 min distal occlusion
Measured: 1 day (One timepoint during single visit)
Microvascular turtuosity
Turtuosity of skin microvasculature of hand and foot with OCTA at rest and after 5 min distal occlusion
Measured: 1 day (One timepoint during single visit)
Secondary outcomes (4)
Blood pressure
Upper arm blood pressure and leg systolic blood pressure
Measured: 1 day (One timepoint during single visit)
Endothelial function
Flow-mediated dilation of brachial and common femoral artery with ultrasound
Measured: 1 day (One timepoint during single visit)
Arterial stiffness
Pulse wave velocity measured at upper arm (Arteriograph)
Measured: 1 day (One timepoint during single visit)
Arterial stiffness
Pulse wave velocity measured with photoplethysmography sensors at hand and foot
Measured: 1 day (One timepoint during single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start18 May 2021
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular EndotheliumStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Heiss, Prof., Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897191
- Sponsor's protocol ID
- OCTA1
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depending on outcome, we may publish IPD.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Age-dependent Reference Values for Microvascular Structure and Function in Healthy Participant Together With Macrovascular Function With Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04897191
- Acronym / sponsor ID
- OCTA1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 21 May 2021 (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.
The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. How healthy ageing affects the smallest blood vessels (microcirculation) and is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation. We have developed an automated software (OCTAVA) to determine metrics to characterise the microcirculation on the layers of density, diameter and tortuosity.
In the current study we aim at providing reference values of these metrics in hands and feet of healthy people according to age together with macrovascular function in arms and legs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: AgeHealthy people age 20-70 years |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults aiming at n=10 of each decade
Key inclusion criteria (1 listed)
- Healthy, 20-70 years, BMI 20-30 kg/m^2
Key exclusion criteria (1 listed)
- Diabetes mellitus, symptoms of acute infection, cardiac arrhythmias, active malignancy, clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication, active vasoactive medication.
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 |
|---|---|---|
| AgeDetermination of age-dependence | Other | Healthy |
Primary outcome
Microvascular density
Time frame: 1 day (One timepoint during single visit)
Density of skin microvasculature of hand and foot with OCTA at rest and after 5 min distal occlusion
Microvascular diameter
Time frame: 1 day (One timepoint during single visit)
Diameter of skin microvasculature of hand and foot with OCTA at rest and after 5 min distal occlusion
Microvascular turtuosity
Time frame: 1 day (One timepoint during single visit)
Turtuosity of skin microvasculature of hand and foot with OCTA at rest and after 5 min distal occlusion
4 secondary outcomes
Blood pressure
Time frame: 1 day (One timepoint during single visit)
Endothelial function
Time frame: 1 day (One timepoint during single visit)
Arterial stiffness
Time frame: 1 day (One timepoint during single visit)
Arterial stiffness
Time frame: 1 day (One timepoint during single visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No. Depending on outcome, we may publish IPD.
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.
Danuta Sampson, Dr. contact
Christian Heiss, Prof. principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Endothelium and Microvascular Circulation, run by University of Surrey at 1 site in United Kingdom.
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 1 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 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Christian Heiss, Prof. (+441737231749, c.heiss@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular density (time frame: 1 day (One timepoint during single visit)). The study lists 3 primary outcomes in all. 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 21 May 2021; AzTrials last refreshed its copy on 27 Oct 2026.