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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05563116
Study type Observational
Source Saint Antoine University Hospital
Contact
Status Completed
Phase
Start date June 1, 2013
Completion date April 30, 2019

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