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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05563116
Other study ID # CAC-HIV
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2013
Est. completion date April 30, 2019

Study information

Verified date April 2023
Source Saint Antoine University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 689
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Franck Boccara

Outcome

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