Clinical trial NCT05563116: French CAC-HIV Cohort Study
Official title: Coronary Artery Calcium Score in People Living With HIV: the French HIV-CAC Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Calcification
HIV Infections
Keywords: Cardiovascular risk stratification
Primary cardiovascular prevention
Intermediate cardiovascular risk
France
Lead sponsor: Saint Antoine University Hospital
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 689
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients referred to one of our two study centers for cardiovascular assessment as part of their routine care.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Computed tomography coronary artery calcium (CAC) score using the Agatston score
timeFrame: One test was performed between June 2013 and April 2016
Secondary outcomes:
measure: Distribution of cardiovascular risk factors
timeFrame: One assessment was performed between June 2013 and April 2016
measure: Rate of carotid and femoral plaques
timeFrame: One assessment was performed between June 2013 and April 2016
measure: Distribution of cardiovascular risk scores (ASCVD and HEART score): low, median and high level.
timeFrame: One assessment was performed between June 2013 and April 2016
Other outcomes:
Locations:
Study officials:
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