French CAC-HIV Cohort Study

Franck Boccara

Status: Completed

Conditions: HIV Infections; Coronary Artery Calcification

Treatments: Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup)

Study type: Observational

Funder types: Other

Identifiers

NCT05563116

CAC-HIV

Details and patient eligibility

About

Clinical study:

• Methods: observational transversal two-arm cohort study including adults living with HIV (PLHIV) and HIV negative subjects (HIV-) at intermediate cardiovascular risk. No study specific interventions were performed.
• Participants: consecutively recruited at two large public hospitals in Paris and Annecy, France where participants were referred for routine cardiac risk stratification.
• Recruitment: was from June 2013 until April 2016.
• Data: anonymous study data were collected during the ambulatory visit. No follow-up was conducted.

Study objectives:

• Primary: compare coronary artery calcification (CAC) score between PLHIV and HIV- in order to bridge gaps in current knowledge.
• Secondary: assess parameters linked to CAC score including predictors and their prevalence, association with carotid/femoral atherosclerosis, and cardiovascular risk scores (ASCVD and HEART score).

Study hypotheses:

• Primary: CAC scores would not be different between PLHIV and HIV-
• Secondary: prevalence of traditional CV risk factors would be lower in PLHIV but that HIV-related nontraditional CV risk factors (including lower grade chronic inflammation, immune dysregulation, and ARV exposure duration) would be associated with higher CAC scores and higher CV risk scores

Study Rational:

• PLHIV have an increased risk of atherosclerotic cardiovascular events compared to the general population. Primary prevention for PLHIV is important but challenging as traditional cardiovascular risk scores do not account for HIV-related factors.
• Computed tomography coronary artery calcium (CAC) score using the Agatston score is useful for detecting and quantifying coronary calcifications. In the general population, CAC score is predictive of future cardiovascular events.

Enrollment: 689 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide informed consent
• Present one or more cardiovascular risk factor
• Complete comprehensive cardiovascular assessment including a valid CAC score, vascular evaluation, interview for demographic, clinical and medical history and a medical workup.

Exclusion criteria

• Age younger than 18 years old
• History of established cardiovascular disease.

Trial design

689 participants in 2 patient groups

People living with HIV (PLHIV)

Description:

Adults over 18 living with HIV. Participants were referred to one of our two study centers for cardiovascular assessment as part of their routine care. PLHIV are at intermediate cardiovascular risk, they present at least one cardiovascular risk factor without established cardiovascular disease. NB: all tests performed are part of routine care for cardiac prevention in France (no study specific interventions were performed.)

Treatment:

Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup)

HIV negative subjects

Description:

Adults over 18 without HIV infection. Participants were referred to one of our two study centers for cardiovascular assessment as part of their routine care. HIV- subjects are at intermediate cardiovascular risk, they present at least one cardiovascular risk factor without established cardiovascular disease. NB: all tests performed are part of routine care for cardiac prevention in France (no study specific interventions were performed.)

Treatment:

Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup)