REtinaL Imaging & Ambulatory BLood PrEssure (RELIABLE)

March 11, 2022 updated by: University of Edinburgh

REtinaL Imaging & Ambulatory BLood PrEssure: Validating Ultra-widefield Retinal Imaging Derived Biomarkers Against Ambulatory Blood Pressure

High blood pressure is a common condition which generally does not have any symptoms. Its estimated that around one third of people with high blood pressure do not know they have it. The back of the eye called the retina is one of the few places in the human body allowing easy observation of blood vessels. This study aims to see if simple non-invasive imaging of the blood vessels of the retina will highlight people with high blood pressure.

Study Overview

Status

Completed

Detailed Description

This will be a prospective, single centre study recruiting patients who are attending the ambulatory blood pressure clinic at the Western General Hospital. Suitable patients will be approached, and if they consent will have pictures of the back of each of their eyes taken. These pictures will then be reviewed, with certain measurements taken of the small blood vessels which can been seen at the back of the eye. These measurements will then be compared to the participants blood pressure readings to see if they might accurately correlate to blood pressure.

Study Type

Observational

Enrollment (Actual)

591

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • City Of Edinburgh
      • Edinburgh, City Of Edinburgh, United Kingdom, EH4 2XU
        • Clinical Research Centre, Western General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants attending a hypertensive clinic at the Western General Hospital in Edinburgh will be asked to consent to ultra-wide field retinal imaging, subject to the inclusion and exclusion criteria below. It is expected that between 25 and 50 participants per week attend the clinic, of which approximately 50% are attending without a known diagnosis of hypertension.

Description

Inclusion Criteria:

  • Attending ambulatory blood pressure clinic
  • Able to undertake ambulatory BP measurement
  • Able to undertake single clinic-based BP measurement
  • Able to undergo UWF retinal imaging with a SLO
  • Aged 18 to 90
  • Able to give informed consent

Exclusion Criteria:

  • People with known history of retinal surgery
  • People under the age of 18 years.
  • People that cannot: manoeuvre themselves to the SLO unaided, sit upright in a chair or wheelchair or position themselves comfortably for imaging.
  • People with epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does retinal arteriovenous ratio correlate to systolic blood pressure
Time Frame: 1 day
Retinal arteriovenous ratio (as measured by ultra-wide field imaging) will be correlated to mean daytime systolic blood pressure (as measured by 24-hour ambulatory blood pressure monitoring)
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does retinal arteriovenous ratio correlate to clinic systolic blood pressure
Time Frame: 1 day
Retinal arteriovenous ratio (as measured by ultra-wide field imaging) will be correlated to clinic systolic blood pressure.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Actual)

December 9, 2019

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC18080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

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