French CAC-HIV 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.

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Key information

Conditions

Coronary Artery Calcification Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: Non-invasive peripheral ultrasound (part of routine workup), Blood samples (part of routine workup)

Primary outcomes

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

Secondary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Franck Boccara

Other

Registry information

Official study title

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

Acronym: CAC-HIV

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: Oct 3, 2022
Registry last updated: Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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