ARIA to Predict Coronary Artery Disease in HIV-infected Individuals

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874221
• Other study ID #: ARIA protocol v.1. 21012019
• Status: Completed
• Start date: May 7, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hiv
• Myocardial Ischemia

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary atherosclerosis defined as the presence of any plaque in one or more coronary artery segments		1 year
Secondary	Presence of any CAC, Presence of significant CAC, Obstructive coronary artery disease		1 year