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Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)

Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06379295
Acronym
CALCOTEP
Enrollment
200
Registered
2024-04-23
Start date
2024-06-06
Completion date
2024-07-22
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Calcification, Coronary Artery Disease

Keywords

Coronary Disease, Coronary Artery Calcium, Cardiovascular Diseases, 18F-FDG PET/CT (Flourine-18 fluorodeoxyglucose positron emission tomography/computed tomography), Enhanced CT (computed tomography)

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.

Interventions

OTHERQuestionnaire

Self-administered questionnaire to assess the participants risk factors, history of heart disease and medications.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of moderate calcification artery calcium (CAC) in participants without history of cardiac diseaseBaselineIn participants who had neither history of cardiac disease nor cardiology follow-up, the proportion of those with at least moderate CAC

Secondary

MeasureTime frameDescription
Prevalence of coronary heart disease among participantsBaselineProportion of participants with history of coronary heart disease, according to questionnaire data
Correlation of CAC with the medical indication for PET imagingBaselineDividing participants into subgroups according to PET indication, determine in which subgroup the proportion of participants with at least moderate CAC is the highest
Prevalence of CAC in young participants (< 45 years old)BaselineProportion of young participants with at least mild CAC
Prevalence of moderate CAC in participants not taking low-cholesterol drugBaselineIn participants not taking low-cholesterol drug, proportion of them with at least moderate CAC
Prevalence of no CAC in participants taking statinsBaselineIn participants taking statins, proportion of them without CAC

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026