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

NCT ID: NCT06379295

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-06

Study Completion Date

2024-07-22

Brief Summary

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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

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Conditions

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Coronary Artery Disease Coronary Artery Calcification

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire d'Orléans

Orléans, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 2407762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12560277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22910756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28283309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30879355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37962596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34147446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36284402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27089854 (View on PubMed)

Other Identifiers

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CHUO-2024-05

Identifier Type: -

Identifier Source: org_study_id

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