Coronary Artery Disease Clinical Trial
— CALCOTEPOfficial title:
Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)
NCT number | NCT06379295 |
Other study ID # | CHUO-2024-05 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 21, 2024 |
Est. completion date | May 21, 2025 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 21, 2025 |
Est. primary completion date | May 21, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire d'Orléans | Orléans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of moderate calcification artery calcium (CAC) in participants without history of cardiac disease | In participants who had neither history of cardiac disease nor cardiology follow-up, the proportion of those with at least moderate CAC | Baseline | |
Secondary | Prevalence of coronary heart disease among participants | Proportion of participants with history of coronary heart disease, according to questionnaire data | Baseline | |
Secondary | Correlation of CAC with the medical indication for PET imaging | Dividing participants into subgroups according to PET indication, determine in which subgroup the proportion of participants with at least moderate CAC is the highest | Baseline | |
Secondary | Prevalence of CAC in young participants (< 45 years old) | Proportion of young participants with at least mild CAC | Baseline | |
Secondary | Prevalence of moderate CAC in participants not taking low-cholesterol drug | In participants not taking low-cholesterol drug, proportion of them with at least moderate CAC | Baseline | |
Secondary | Prevalence of no CAC in participants taking statins | In participants taking statins, proportion of them without CAC | Baseline |
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