French CAC-HIV Cohort Study

Sponsor

Franck Boccara (Other)

Overall Status

Completed

CT.gov ID

NCT05563116

Collaborator

(none)

689

Enrollment

70.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Calcification HIV Infections	Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup)

Study Design

Study Type:

Observational

Actual Enrollment :

689 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Apr 30, 2019

Actual Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
People living with HIV (PLHIV) 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.)	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. Other Names: Non-invasive peripheral ultrasound (part of routine workup) Blood samples (part of routine workup)
HIV negative subjects 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.)	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. Other Names: Non-invasive peripheral ultrasound (part of routine workup) Blood samples (part of routine workup)

Arm

Intervention/Treatment

People living with HIV (PLHIV)

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.)

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.

Other Names:

Non-invasive peripheral ultrasound (part of routine workup)

Blood samples (part of routine workup)

HIV negative subjects

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.)

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

Other Names:

Non-invasive peripheral ultrasound (part of routine workup)

Blood samples (part of routine workup)

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.