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OpenTrials
Completed

NCT Number: NCT06379295

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Calcification Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire d'Orléans

Orléans, 45067, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. Prevalence of moderate calcification artery calcium (CAC) in participants without history of cardiac disease

    Time frame: Baseline

    In participants who had neither history of cardiac disease nor cardiology follow-up, the proportion of those with at least moderate CAC

Secondary outcomes

  1. Prevalence of coronary heart disease among participants

    Time frame: Baseline

    Proportion of participants with history of coronary heart disease, according to questionnaire data

  2. Correlation of CAC with the medical indication for PET imaging

    Time frame: 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

  3. Prevalence of CAC in young participants (< 45 years old)

    Time frame: Baseline

    Proportion of young participants with at least mild CAC

  4. Prevalence of moderate CAC in participants not taking low-cholesterol drug

    Time frame: Baseline

    In participants not taking low-cholesterol drug, proportion of them with at least moderate CAC

  5. Prevalence of no CAC in participants taking statins

    Time frame: Baseline

    In participants taking statins, proportion of them without CAC

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Acronym: CALCOTEP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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