Healthy Age-dependent Reference Values for Microvascular Structure and Function

Arterial Stiffness Clinical Trial

Official title:

Assessing Age-dependent Reference Values for Microvascular Structure and Function in Healthy Participant Together With Macrovascular Function With Optical Coherence Tomography Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897191
• Other study ID #: OCTA1
• Status: Recruiting
• Start date: May 18, 2021
• Est. completion date: August 2021

Study information

• Verified date: May 2021
• Source: University of Surrey
• Contact: Christian Heiss, Prof.
• Phone: +441737231749
• Email: c.heiss[@]surrey.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Stiffness
• Healthy Ageing
• Vascular Endothelium

Intervention

Other:
• Age
Determination of age-dependence

Locations

Country	Name	City	State
United Kingdom	University of Surrey	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

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