NCT05563116

French CAC-HIV Cohort Study

Coronary Artery Calcium Score in People Living With HIV: the French HIV-CAC Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 689 (actual)
• Sponsor: Franck Boccara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Calcification
• HIV Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Computed tomography coronary artery calcium (CAC) score (part of routine workup)	Agatston method quantified coronary calcification. A prospectively ECG-triggered, non-contrasted CAC score used a non-enhanced low radiation cardiac CT scan provided onsite at both centers. Quantification of CAC was performed using a SOMATOM Definition Edge or SOMATOM Force (Siemens Medical Solutions) with standard mediastinal parameters (width, 350 Hounsfield units; level, 50 Hounsfield units), and according to the current guidelines for CAC scoring of non-contrast non-cardiac chest CT scans.

Timeline

• Start date: 2013-06-01
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2022-10-03
• Last updated: 2023-04-18