Coronary Artery CalcificationCAC-HIVNCT05563116
French CAC-HIV Cohort Study
An observational study of Coronary Artery Calcification and HIV Infections, run by Franck Boccara.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Calcification, HIV Infections
- What is being tested?
- Computed tomography coronary artery calcium (CAC) score (part of routine workup)
- How many people
- 689 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients referred to one of our two study centers for cardiovascular assessment as part of their routine care.
Who may be able to join
- 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.
Who cannot join
- Age younger than 18 years old
- History of established cardiovascular disease.
About this study
Official title: 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.
Read more
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
- Being tested
- Computed tomography coronary artery calcium (CAC) score (part of routine workup)
- Keywords
- Cardiovascular risk stratification, Primary cardiovascular prevention, Intermediate cardiovascular risk, France
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography coronary artery calcium (CAC) score (part of routine workup)Diagnostic test
Also called Non-invasive peripheral ultrasound (part of routine workup), Blood samples (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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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.) Receives: Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One test was performed between June 2013 and April 2016
Secondary outcomes (3)
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.
Measured: One assessment was performed between June 2013 and April 2016
Rate of carotid and femoral plaques
The investigators will use non-invasive ultrasound to measure carotid and femoral atherosclerosis.
Measured: One assessment was performed between June 2013 and April 2016
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.
Measured: One assessment was performed between June 2013 and April 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Jun 2013
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 689 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franck Boccara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franck Boccara, Saint Antoine University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563116
- Sponsor's protocol ID
- CAC-HIV
- Acronym
- CAC-HIV
- Status last verified
- Apr 2023
- First submitted
- 23 Sep 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous study data may be made available upon specific request, please contact Pr. Franck Boccara (franck.boccara@aphp.fr) for more information.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Calcium Score in People Living With HIV: the French HIV-CAC Cohort Study
- ClinicalTrials.gov ID
- NCT05563116
- Acronym / sponsor ID
- CAC-HIV / CAC-HIV
- Conditions
- Coronary Artery Calcification, HIV Infections
- Keywords
- Cardiovascular risk stratification, Primary cardiovascular prevention, Intermediate cardiovascular risk, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- Franck BoccaraUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with HIV (PLHIV) | – | Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup)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.) |
| HIV negative subjects | – | Diagnostic Test: Computed tomography coronary artery calcium (CAC) score (part of routine workup)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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred to one of our two study centers for cardiovascular assessment as part of their routine care.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Age younger than 18 years old
- History of established cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography coronary artery calcium (CAC) score (part of routine workup)Also: Non-invasive peripheral ultrasound (part of routine workup), Blood samples (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. | Diagnostic test | HIV negative subjects, People living with HIV (PLHIV) |
Primary outcome
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
3 secondary outcomes
Distribution of cardiovascular risk factors
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided. Anonymous study data may be made available upon specific request, please contact Pr. Franck Boccara (franck.boccara@aphp.fr) for more information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Calcification and HIV Infections, run by Franck Boccara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed tomography coronary artery calcium (CAC) score using the Agatston score (time frame: One test was performed between June 2013 and April 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.