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

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 Overview

• Status: Recruiting
• Conditions: Arterial Stiffness; Vascular Endothelium; Microvascular Circulation; Healthy Ageing
• Intervention / Treatment: Other: Age

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Christian Heiss, Prof.; Phone Number: +441737231749; Email: c.heiss@surrey.ac.uk
• Study Contact Backup: Name: Danuta Sampson, Dr.; Email: danuta.sampson@surrey.ac.uk

Study Locations

• United Kingdom
  • Guildford, United Kingdom, GU2 7XH
    • Recruiting
    • University of Surrey
    • Contact: Mariam Bapir; Email: m.bapir@surrey.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults aiming at n=10 of each decade

Description

Inclusion criteria:

Healthy, 20-70 years, BMI 20-30 kg/m^2

Exclusion criteria:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Healthy people age 20-70 years	Other: Age; Determination of age-dependence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Upper arm blood pressure and leg systolic blood pressure	1 day (One timepoint during single visit)
Endothelial function	Flow-mediated dilation of brachial and common femoral artery with ultrasound	1 day (One timepoint during single visit)
Arterial stiffness	Pulse wave velocity measured at upper arm (Arteriograph)	1 day (One timepoint during single visit)
Arterial stiffness	Pulse wave velocity measured with photoplethysmography sensors at hand and foot	1 day (One timepoint during single visit)

Collaborators and Investigators

• Sponsor: University of Surrey
• Investigators: Principal Investigator: Christian Heiss, Prof., University of Surrey

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OCTA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Depending on outcome, we may publish IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No