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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Arterial Occlusive Diseases Arteriosclerosis Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Coronary Artery Disease Coronary Disease Genital Diseases HIV Infections Heart Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Myocardial Ischemia RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Coronary atherosclerosis defined as the presence of any plaque in one or more coronary artery segments

Time frame: 1 year

Secondary outcomes

Presence of any CAC, Presence of significant CAC, Obstructive coronary artery disease

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Mar 14, 2019
Registry last updated: Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed