French CAC-HIV Cohort Study

Completed

• Conditions: HIV Infections; Coronary Artery Calcification
• Interventions: Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup)

• Registration Number: NCT05563116
• Lead Sponsor: Franck Boccara

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 689

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV negative subjects	Computed tomography coronary artery calcium (CAC) score (part of routine workup)	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.)
People living with HIV (PLHIV)	Computed tomography coronary artery calcium (CAC) score (part of routine workup)	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.)

Primary Outcome Measures

Name	Time	Method
Computed tomography coronary artery calcium (CAC) score using the Agatston score	One test was performed between June 2013 and April 2016	The investigators will measure the CAC score using the Agatston score.; Agatston score scale: 0 (lowest risk) to \>400 (severely increased risk); Agatston score interpretation: * lower scores mean lower risk; * higher scores mean higher risk; We will measure Agatston score then assign patients to one of four groups: CAC score = 0; CAC score 1-99, CAC score 100-399, CAC score \> 400

Secondary Outcome Measures

Name	Time	Method
Distribution of cardiovascular risk factors	One assessment was performed between June 2013 and April 2016	The investigators will measure the prevalence of traditional cardiovascular risk factors by medical interview, review of medical records and biochemical laboratory tests.; - Traditional cardiovascular risk factors include: tobacco use, diabetes (fasting glucose and anti-diabetic drug use), hypertension (blood pressure measurement and antihypertensive drug use), lipid abnormalities (lipid panel and lipid-lowering drug use); We will measure the prevalence of non-traditional HIV-related cardiovascular risk factors by medical interview, medical records review and biochemical laboratory tests.; - Non-traditional HIV-related cardiovascular risk factors include: HIV duration, antiretroviral regimen and duration, viral load, lymphocyte count and nadir.
Rate of carotid and femoral plaques	One assessment was performed between June 2013 and April 2016	The investigators will use non-invasive ultrasound to measure carotid and femoral atherosclerosis.
Distribution of cardiovascular risk scores (ASCVD and HEART score): low, median and high level.	One assessment was performed between June 2013 and April 2016	The investigators will calculate cardiovascular risk using the ASCVD model and the HEART model.