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

NCT06379295 | Completed

• 1 other identifier: CHUO-2024-05
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Coronary Artery Calcification

Keywords

Coronary Disease; Coronary Artery Calcium; Cardiovascular Diseases; 18F-FDG PET/CT (Flourine-18 fluorodeoxyglucose positron emission tomography/computed tomography); Enhanced CT (computed tomography)

Outcome Measures

Primary Outcomes (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

  Baseline

Secondary Outcomes (5)

• Prevalence of coronary heart disease among participants

  Baseline

• Correlation of CAC with the medical indication for PET imaging

  Baseline

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

  Baseline

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

  Baseline

• Prevalence of no CAC in participants taking statins

  Baseline

Interventions

Questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Orléans

Orléans, 45067, France

Location

Related Publications (9)

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  PMID: 2407762 BACKGROUND

• 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.

  PMID: 12560277 BACKGROUND

• 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.

  PMID: 22910756 BACKGROUND

• 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.

  PMID: 28283309 BACKGROUND

• 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.

  PMID: 30879355 BACKGROUND

• 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.

  PMID: 37962596 BACKGROUND

• 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.

  PMID: 34147446 BACKGROUND

• 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.

  PMID: 36284402 BACKGROUND

• 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.

  PMID: 27089854 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Cardiovascular Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: June 6, 2024
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

FR (1)