ARIA to Predict Coronary Artery Disease in HIV-infected Individuals

Completed

• Conditions: Coronary Artery Disease; Hiv

• Registration Number: NCT03874221
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2019-05-07
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary atherosclerosis defined as the presence of any plaque in one or more coronary artery segments	1 year

Secondary Outcome Measures

Name	Time	Method
Presence of any CAC, Presence of significant CAC, Obstructive coronary artery disease	1 year

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong