NCT04897191

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

1 month

First QC Date

May 18, 2021

Last Update Submit

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

Other: Age

Interventions

AgeOTHER

Determination of age-dependence

Healthy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Christian Heiss, Prof.

    University of Surrey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Heiss, Prof.

CONTACT

Danuta Sampson, Dr.

CONTACT

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.

Locations