French CAC-HIV Cohort Study

NCT ID: NCT05563116

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 689 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-01
• Study Completion Date: 2019-04-30

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.

Conditions

Coronary Artery Calcification; HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.)

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

Intervention Type: DIAGNOSTIC_TEST

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.

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.)

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Non-invasive peripheral ultrasound (part of routine workup); Blood samples (part of routine workup)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Franck Boccara

OTHER

Sponsor Role: lead

Responsible Party

Franck Boccara

Prinicipal Investigator, Senior Cardiologist, Professor of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

CAC-HIV

Identifier Type: -

Identifier Source: org_study_id