- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04118205
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
Conditions
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.
Sponsor
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
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Recruiting
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate