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

Completed

• Conditions: Coronary Artery Disease; Coronary Artery Calcification

• Registration Number: NCT06379295
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-23
• Study Start: 2024-06-06
• Primary Completion: 2024-07-22
• Study Completion: 2024-07-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of moderate calcification artery calcium (CAC) in participants without history of cardiac disease	Baseline	In participants who had neither history of cardiac disease nor cardiology follow-up, the proportion of those with at least moderate CAC

Secondary Outcome Measures

Name	Time	Method
Prevalence of coronary heart disease among participants	Baseline	Proportion of participants with history of coronary heart disease, according to questionnaire data
Prevalence of moderate CAC in participants not taking low-cholesterol drug	Baseline	In participants not taking low-cholesterol drug, proportion of them with at least moderate CAC
Correlation of CAC with the medical indication for PET imaging	Baseline	Dividing 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)	Baseline	Proportion of young participants with at least mild CAC
Prevalence of no CAC in participants taking statins	Baseline	In participants taking statins, proportion of them without CAC

Trial Locations

Locations (1)

Centre Hospitalier Universitaire d'Orléans; 🇫🇷 Orléans, France