Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-21 @ 1:51 AM
Study NCT ID:
NCT06379295
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2024-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of moderate calcification artery calcium (CAC) in participants without history of cardiac disease', 'timeFrame': 'Baseline', 'description': 'In participants who had neither history of cardiac disease nor cardiology follow-up, the proportion of those with at least moderate CAC'}], 'secondaryOutcomes': [{'measure': 'Prevalence of coronary heart disease among participants', 'timeFrame': 'Baseline', 'description': 'Proportion of participants with history of coronary heart disease, according to questionnaire data'}, {'measure': 'Correlation of CAC with the medical indication for PET imaging', 'timeFrame': 'Baseline', 'description': 'Dividing participants into subgroups according to PET indication, determine in which subgroup the proportion of participants with at least moderate CAC is the highest'}, {'measure': 'Prevalence of CAC in young participants (< 45 years old)', 'timeFrame': 'Baseline', 'description': 'Proportion of young participants with at least mild CAC'}, {'measure': 'Prevalence of moderate CAC in participants not taking low-cholesterol drug', 'timeFrame': 'Baseline', 'description': 'In participants not taking low-cholesterol drug, proportion of them with at least moderate CAC'}, {'measure': 'Prevalence of no CAC in participants taking statins', 'timeFrame': 'Baseline', 'description': 'In participants taking statins, proportion of them without CAC'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Disease', 'Coronary Artery Calcium', 'Cardiovascular Diseases', '18F-FDG PET/CT (Flourine-18 fluorodeoxyglucose positron emission tomography/computed tomography)', 'Enhanced CT (computed tomography)'], 'conditions': ['Coronary Artery Disease', 'Coronary Artery Calcification']}, 'referencesModule': {'references': [{'pmid': '2407762', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12560277', 'type': 'BACKGROUND', '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.'}, {'pmid': '22910756', 'type': 'BACKGROUND', '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."}, {'pmid': '28283309', 'type': 'BACKGROUND', '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.'}, {'pmid': '30879355', 'type': 'BACKGROUND', '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.'}, {'pmid': '37962596', 'type': 'BACKGROUND', '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. 2024 Jun;34(6):4077-4088. doi: 10.1007/s00330-023-10390-z. Epub 2023 Nov 14.'}, {'pmid': '34147446', 'type': 'BACKGROUND', '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.'}, {'pmid': '36284402', 'type': 'BACKGROUND', '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.'}, {'pmid': '27089854', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Calcification artery calcium (CAC) scoring is a valuable tool for determining the risk of major adverse cardiac events.\n\nIt 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.\n\nThe 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.\n\nA 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.\n\nEach patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People aged 18 and over referred for a 18F-FDG PET/CT imaging', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred for a 18F-FDG PT/CT imaging\n* Patients aged 18 and older\n\nExclusion Criteria:\n\n* Patients who already participated in this study (in case of follow-up PET/CT scans)\n* Unusable CT scan due to CT artifacts or poor-quality images\n* Patients referred for a brain 18F-FDG PET/CT imaging\n* Minors,\n* Protected adults\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT06379295', 'acronym': 'CALCOTEP', 'briefTitle': 'Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)', 'organization': {'class': 'OTHER', 'fullName': "Centre Hospitalier Régional d'Orléans"}, 'officialTitle': 'Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)', 'orgStudyIdInfo': {'id': 'CHUO-2024-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Self-administered questionnaire to assess the participants risk factors, history of heart disease and medications.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45067', 'city': 'Orléans', 'country': 'France', 'facility': "Centre Hospitalier Universitaire d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre Hospitalier Régional d'Orléans", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}