ARIA to Predict Coronary Artery Disease in HIV-infected Individuals

NCT03874221 | Completed

• 1 other identifier: ARIA protocol v.1. 21012019
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

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

  1 year

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

: Peripheral blood samples

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Grace Lui

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: May 7, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)