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

October 31, 2024 updated by: Centre Hospitalier Régional d'Orléans

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45067
        • Centre Hospitalier Universitaire d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People aged 18 and over referred for a 18F-FDG PET/CT imaging

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of coronary heart disease among participants
Time Frame: Baseline
Proportion of participants with history of coronary heart disease, according to questionnaire data
Baseline
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
Baseline
Prevalence of CAC in young participants (< 45 years old)
Time Frame: Baseline
Proportion of young participants with at least mild CAC
Baseline
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
Baseline
Prevalence of no CAC in participants taking statins
Time Frame: Baseline
In participants taking statins, proportion of them without CAC
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Actual)

July 22, 2024

Study Completion (Actual)

July 22, 2024

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUO-2024-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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