Clinical trial NCT06379295: Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)
Official title: Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Artery Calcification
Keywords: Coronary Disease
Coronary Artery Calcium
Cardiovascular Diseases
18F-FDG PET/CT (Flourine-18 fluorodeoxyglucose positron emission tomography/computed tomography)
Enhanced CT (computed tomography)
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People aged 18 and over referred for a 18F-FDG PET/CT imaging

Brief summary: Calcification artery calcium (CAC) scoring is a valuable tool for determining the risk of major adverse cardiac events.

It was found that CAC can be quantitatively assessed, by manual scoring or using deep-learning, on low-dose non electrocardiogram-gated, contrast-enhanced or non-enhanced computed tomography (CT-scan) performed in association of PET acquisition, with a good agreement with standard scans.

The purpose of this study is to determine the impact of a systematic coronary artery calcification evaluation in patients undergoing flourine-18 fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) imaging to improve primary prevention of cardiovascular diseases.

A visual calcification artery calcium assessment will be made for each patient, dividing them into four groups: none, mild, moderate or heavy calcification artery calcium. When possible, a calcification artery calcium score will be computed.

Each patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications.


Eligibility criteria: Inclusion Criteria:

* Patients referred for a 18F-FDG PT/CT imaging
* Patients aged 18 and older

Exclusion Criteria:

* Patients who already participated in this study (in case of follow-up PET/CT scans)
* Unusable CT scan due to CT artifacts or poor-quality images
* Patients referred for a brain 18F-FDG PET/CT imaging
* Minors,
* Protected adults
* Pregnant or breastfeeding women

Primary outcomes:
measure: Prevalence of moderate calcification artery calcium (CAC) in participants without history of cardiac disease
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of coronary heart disease among participants
timeFrame: Baseline
measure: Correlation of CAC with the medical indication for PET imaging
timeFrame: Baseline
measure: Prevalence of CAC in young participants (< 45 years old)
timeFrame: Baseline
measure: Prevalence of moderate CAC in participants not taking low-cholesterol drug
timeFrame: Baseline
measure: Prevalence of no CAC in participants taking statins
timeFrame: Baseline
Other outcomes:
Locations:
city: Orléans
country: France
facility: Centre Hospitalier Universitaire d'Orléans
Study officials:
References:
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