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Coronary Artery DiseaseCALCOTEPNCT06379295

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

An observational study of Coronary Artery Disease and Coronary Artery Calcification, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Questionnaire
How many people
200 participants
Where
1 siteFrance
Study dates
6 Jun 2024to 22 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Universitaire d'Orléans

    Orléans, 45067

Other trials in France

About this study

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.

Read more

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.

Being tested
Questionnaire
Keywords
Coronary Disease, Coronary Artery Calcium, Cardiovascular Diseases, 18F-FDG PET/CT (Flourine-18 fluorodeoxyglucose positron emission tomography/computed tomography), Enhanced CT (computed tomography)
Medical subject headings
Coronary Artery Disease, Coronary Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

Secondary outcomes (5)

  1. Prevalence of coronary heart disease among participants

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

    Measured: Baseline

  2. 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

    Measured: Baseline

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

    Proportion of young participants with at least mild CAC

    Measured: Baseline

  4. 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

    Measured: Baseline

  5. Prevalence of no CAC in participants taking statins

    In participants taking statins, proportion of them without CAC

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start6 Jun 2024
  3. Primary completion22 Jul 2024
  4. Study completion22 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06379295
Sponsor's protocol ID
CHUO-2024-05
Acronym
CALCOTEP
Status last verified
Oct 2024
First submitted
18 Apr 2024
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32. doi: 10.1016/0735-1097(90)90282-t.

    PubMed 2407762

  • Darby S, McGale P, Peto R, Granath F, Hall P, Ekbom A. Mortality from cardiovascular disease more than 10 years after radiotherapy for breast cancer: nationwide cohort study of 90 000 Swedish women. BMJ. 2003 Feb 1;326(7383):256-7. doi: 10.1136/bmj.326.7383.256. No abstract available.

    PubMed 12560277

  • Yeboah J, McClelland RL, Polonsky TS, Burke GL, Sibley CT, O'Leary D, Carr JJ, Goff DC, Greenland P, Herrington DM. Comparison of novel risk markers for improvement in cardiovascular risk assessment in intermediate-risk individuals. JAMA. 2012 Aug 22;308(8):788-95. doi: 10.1001/jama.2012.9624.

    PubMed 22910756

  • Hecht H, Blaha MJ, Berman DS, Nasir K, Budoff M, Leipsic J, Blankstein R, Narula J, Rumberger J, Shaw LJ. Clinical indications for coronary artery calcium scoring in asymptomatic patients: Expert consensus statement from the Society of Cardiovascular Computed Tomography. J Cardiovasc Comput Tomogr. 2017 Mar-Apr;11(2):157-168. doi: 10.1016/j.jcct.2017.02.010. Epub 2017 Feb 24.

    PubMed 28283309

  • Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.

    PubMed 30879355

  • Oh HS, Kim TH, Kim JW, Yang J, Lee HS, Lee JH, Park CH. Feasibility and limitations of deep learning-based coronary calcium scoring in PET-CT: a comparison with coronary calcium score CT. Eur Radiol. 2024 Jun;34(6):4077-4088. doi: 10.1007/s00330-023-10390-z. Epub 2023 Nov 14.

    PubMed 37962596

  • Mortensen MB, Dzaye O, Bodtker H, Steffensen FH, Botker HE, Jensen JM, Ronnow Sand NP, Maeng M, Warnakula Olesen KK, Sorensen HT, Kanstrup H, Blankstein R, Blaha MJ, Norgaard BL. Interplay of Risk Factors and Coronary Artery Calcium for CHD Risk in Young Patients. JACC Cardiovasc Imaging. 2021 Dec;14(12):2387-2396. doi: 10.1016/j.jcmg.2021.05.003. Epub 2021 Jun 16.

    PubMed 34147446

  • Pieszko K, Shanbhag A, Killekar A, Miller RJH, Lemley M, Otaki Y, Singh A, Kwiecinski J, Gransar H, Van Kriekinge SD, Kavanagh PB, Miller EJ, Bateman T, Liang JX, Berman DS, Dey D, Slomka PJ. Deep Learning of Coronary Calcium Scores From PET/CT Attenuation Maps Accurately Predicts Adverse Cardiovascular Events. JACC Cardiovasc Imaging. 2023 May;16(5):675-687. doi: 10.1016/j.jcmg.2022.06.006. Epub 2022 Sep 14.

    PubMed 36284402

  • Engbers EM, Timmer JR, Mouden M, Jager PL, Knollema S, Oostdijk AH, Ottervanger JP. Visual estimation of coronary calcium on computed tomography for attenuation correction. J Cardiovasc Comput Tomogr. 2016 Jul-Aug;10(4):327-9. doi: 10.1016/j.jcct.2016.04.002. Epub 2016 Apr 11.

    PubMed 27089854

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Coronary Artery Calcification, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of moderate calcification artery calcium (CAC) in participants without history of cardiac disease (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06379295, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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