French CAC-HIV Cohort Study (CAC-HIV)

April 16, 2023 updated by: Franck Boccara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

689

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computed tomography coronary artery calcium (CAC) score using the Agatston score
Time Frame: 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
One test was performed between June 2013 and April 2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of cardiovascular risk factors
Time Frame: 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.
One assessment was performed between June 2013 and April 2016
Rate of carotid and femoral plaques
Time Frame: One assessment was performed between June 2013 and April 2016
The investigators will use non-invasive ultrasound to measure carotid and femoral atherosclerosis.
One assessment was performed between June 2013 and April 2016
Distribution of cardiovascular risk scores (ASCVD and HEART score): low, median and high level.
Time Frame: One assessment was performed between June 2013 and April 2016
The investigators will calculate cardiovascular risk using the ASCVD model and the HEART model.
One assessment was performed between June 2013 and April 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franck Boccara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAC-HIV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymous study data may be made available upon specific request, please contact Pr. Franck Boccara (franck.boccara@aphp.fr) for more information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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