Coronary Artery Calcification Assessed on PET/CT

Coronary Artery Disease Clinical Trial

— CALCOTEP  

Official title:

Coronary Artery Calcification Assessed on PET/CT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379295
• Other study ID #: CHUO-2024-05
• Status: Not yet recruiting
• Start date: May 21, 2024
• Est. completion date: May 21, 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 ECG-gated, contrast-enhanced or non-enhanced CT scans 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 18F-FDG PET/CT imaging to improve primary prevention of cardiovascular diseases. A visual CAC assessment will be made for each patient, dividing them into four groups: none, mild, moderate or heavy CAC. When possible, a CAC score will be computed. Each patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 21, 2025
• Est. primary completion date: May 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Calcification
• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

References & Publications (9)

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. — View Citation

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. Erratum In: Circulation. 2019 Sep 10;140(11):e649-e650. Circulation. 2020 Jan 28;141(4):e60. Circulation. 2020 Apr 21;141(16):e774. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2023 Nov 14. doi: 10.1007/s00330-023-10390-z. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of moderate 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	Inclusion
Secondary	Prevalence of coronary heart disease among participants	Proportion of participants with history of coronary heart disease, according to questionnaire data	Inclusion
Secondary	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	Inclusion
Secondary	Prevalence of CAC in young participants (< 45 years old)	Proportion of young participants with at least mild CAC	Inclusion
Secondary	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	Inclusion
Secondary	Prevalence of no CAC in participants taking statins	In participants taking statins, proportion of them without CAC	Inclusion