Healthy Age-dependent Reference Values for Microvascular Structure and Function
Assessing Age-dependent Reference Values for Microvascular Structure and Function in Healthy Participant Together With Macrovascular Function With Optical Coherence Tomography Angiography
1 other identifier
observational
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
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
May 18, 2021
CompletedStudy Start
First participant enrolled
May 18, 2021
CompletedFirst Posted
Study publicly available on registry
May 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMay 21, 2021
May 1, 2021
1 month
May 18, 2021
May 20, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Microvascular density
Density of skin microvasculature of hand and foot with OCTA at rest and after 5 min distal occlusion
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
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
1 day (One timepoint during single visit)
Secondary Outcomes (4)
Blood pressure
1 day (One timepoint during single visit)
Endothelial function
1 day (One timepoint during single visit)
Arterial stiffness
1 day (One timepoint during single visit)
Arterial stiffness
1 day (One timepoint during single visit)
Study Arms (1)
Healthy
Healthy people age 20-70 years
Interventions
Eligibility Criteria
Healthy adults aiming at n=10 of each decade
You may qualify if:
- Healthy, 20-70 years, BMI 20-30 kg/m\^2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Surrey
Guildford, GU2 7XH, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Heiss, Prof.
University of Surrey
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2021
First Posted
May 21, 2021
Study Start
May 18, 2021
Primary Completion
July 1, 2021
Study Completion
August 1, 2021
Last Updated
May 21, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
Depending on outcome, we may publish IPD.