ARIA to Predict Coronary Artery Disease in HIV-infected Individuals

Automatic Retinal Image Analysis (ARIA) to Predict Coronary Artery Disease in HIV-infected Individuals

With effective anti-retroviral therapy, non-communicable diseases, such as cardiovascular diseases, have become the major cause of morbidity and mortality for people living with HIV. There is only limited data evaluating the burden and risk factors of cardiovascular disease in the Asian HIV-infected population. Accurate non-invasive tools for prediction of cardiovascular disease, particularly in Asian HIV-infected populations, are urgently needed. Recently, more detailed evaluation of the complex retinal vasculature has been made feasible with advances in digitalized retinal imaging techniques.

This study aims 1. to determine the prevalence of coronary atherosclerosis and obstructive coronary artery disease HIV-infected individuals with one or more cardiovascular disease risk factors in Asia. 2. to determine the performance of automatic retinal image analysis (ARIA) in predicting the risk of coronary artery disease in HIV-infected individuals, as compared to traditional risk prediction tools. Patients will undergo a coronary CT angiogram, followed by an automatic retinal image analysis within 4 weeks post completion of CT angiogram.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Hiv

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All HIV-infected individuals followed up in Metabolic Research Clinic and Infectious Diseases clinic of the Prince of Wales Hospital will be screened for eligibility.

Description

Inclusion Criteria:

• Positive anti-HIV antibody
• Age 30 or above
• Presence of one or more risk factors for cardiovascular disease

Exclusion Criteria:

• Presence of overt coronary artery disease
• Impaired renal function
• Allergy to intravenous contrast
• Pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coronary atherosclerosis defined as the presence of any plaque in one or more coronary artery segments	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Presence of any CAC, Presence of significant CAC, Obstructive coronary artery disease	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Grace Lui, CUHK

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: ARIA protocol v.1. 21012019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No