NCT05563116

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
689

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

5.9 years

First QC Date

September 23, 2022

Last Update Submit

April 16, 2023

Conditions

Coronary Artery CalcificationHIV Infections

Keywords

Cardiovascular risk stratificationPrimary cardiovascular preventionIntermediate cardiovascular riskFrance

Outcome Measures

Primary Outcomes (1)

  • Computed tomography coronary artery calcium (CAC) score using the Agatston score

    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 Outcomes (3)

  • Distribution of cardiovascular risk factors

    One assessment was performed between June 2013 and April 2016

  • Rate of carotid and femoral plaques

    One assessment was performed between June 2013 and April 2016

  • Distribution of cardiovascular risk scores (ASCVD and HEART score): low, median and high level.

    One assessment was performed between June 2013 and April 2016

Study Arms (2)

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)

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)

Interventions

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.

Also known as: Non-invasive peripheral ultrasound (part of routine workup), Blood samples (part of routine workup)
HIV negative subjectsPeople living with HIV (PLHIV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients referred to one of our two study centers for cardiovascular assessment as part of their routine care.

You may qualify if:

  • 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.

You may not qualify if:

  • Age younger than 18 years old
  • History of established cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prinicipal Investigator, Senior Cardiologist, Professor of Cardiology

Study Record Dates

First Submitted

September 23, 2022

First Posted

October 3, 2022

Study Start

June 1, 2013

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

April 18, 2023

Record last verified: 2023-04