Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate

Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images Clinical Trial

Official title:

A Non-Interventional Pilot Study to Evaluate A Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814680
• Other study ID #: D9080C00001
• Status: Completed
• Start date: November 8, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: December 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a non-interventional pilot study with the following objectives: - Establish scalable methodology for collection of retinal images, blood pressure (BP) and laboratory-based assessments - Compare the results of a machine-learning algorithm in predicting BP, glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) from digital retinal images with clinical and laboratory-based measures - Determine the required sample size needed to support a future study to fully validate the machine-learning algorithm

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 130 Years

Eligibility

Inclusion Criteria:

• Participant must be = 35 years of age, at the time of signing the informed consent.
• With or without DM (at least 50% of participants will have an HbA1c = 6.5%* and/or a known diagnosis of DM)
• Male or female (at least 40% of participants must be male, and at least 40% must be female)
• Capable of giving signed informed consent as described in Appendix A

Exclusion Criteria:

• As judged by the investigator, any evidence of a medical condition which in the investigator's opinion makes it undesirable for the participant to participate in the study for example, but not limited to, if a participant is critically unwell or requiring ongoing emergency treatment
• Any known eye condition that may preclude clear imaging of the retina for example; cataracts
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
• Previous enrolment in the present study with the exception of roll-in participants who may be re-screened and re-enrolled.

Related Conditions & MeSH terms

• Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images

Locations

Country	Name	City	State
Kenya	Research Site	Nairobi
Kenya	Research Site	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Iqvia Pty Ltd

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess successful use of methodology for retinal image acquisition, BP (ABPM or manual), HbA1C (laboratory based or point of care test) and e-GFR measurement.	Proportion of participants with completed study procedures and interpretable results including both retinal images, systolic and diastolic BP (ABPM or manual), HbA1c (laboratory based or point of care test) and eGFR at Visit 1	up to 66 day

External Links

•   Redacted CSR synopsis