- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02011061
Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography (C-Sub320)
Prospective International Study of Coronary Substraction Using 320 Row-detector CT
Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction.
The primary hypothesis of the study is:
- Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to conventional CCTA on a per-patient basis
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
CCTA is a very important clinical method for the clinical evaluation of patients with chest pain of potential cardiac ischemic origin. However Coronary calcification and/or previously implanted coronary stents may limit the diagnostic accuracy of CCTA. A novel approach - coronary calcium subtraction - has been developed to potentially overcome this limitation.
- Study Objective: To assess diagnostic accuracy using coronary calcium subtraction coronary CT angiography (CCTA) as compared to conventional CCTA.
- Material and Methods: A total of 200 patients with suspected or known coronary artery disease (CAD) who have been referred for invasive coronary angiography (ICA) will prior to ICA undergo additional research CCTA with the newly developed coronary calcium subtraction protocol. Based on the coronary calcium scan (CS), coronary calcium score will be calculated according to the Agatston score. Conventional contrast enhanced CCTA studies will be analyzed for image quality and the presence and extent of coronary stenosis. Using a dedicated algorithm, subtraction will be performed on all datasets to obtain CCTA subtraction images. Subtracted images will be analyzed similar to the conventional CCTA images. ICA will serve as the gold standard. Image quality will be compared between conventional and subtracted CCTA. In addition, diagnostic accuracy in the evaluation of coronary stenosis as determined on ICA will be compared. Finally, factors influencing the performance of coronary calcium subtraction will be evaluated.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Copenhagen, Danmark, 2100
- Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
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Maryland
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Bethesda, Maryland, Förenta staterna, 20892
- National Heart, Lung and Blood Institute
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Age > 55 Years
- Scheduled for invasive coronary angiography
- Logistically possible to perform CCTA before invasive evaluation
Exclusion Criteria:
- Known Iodine-contrast allergy
- Estimated GFR below 50 ml/min
- Atrial fibrillation or other persistence cardiac arrythmia
- Contraindication to betablockers (bronchospasm, LVEF less than 40%)
- Implanted PM or ICD
- Previous mechanical heart valve surgery
- Inability to maintain breath-hold for at least 5 sec
- Patient-related condition resulting the inability of the patient to understand the informed consent form of the study
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Diagnostic accuracy of Coronary Subtraction Coronary CT angiography
Tidsram: Within 90 days of ICA and CCTA
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Sensitivity, Specificity, Negative and Positive predictive value of Coronary Subtraction CT angiography by visual assessment to identify a >50% coronary stenosis as defined by invasive coronary angiography on a patient by patient level.
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Within 90 days of ICA and CCTA
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Coronary CT angiography reader confidence
Tidsram: Within 90 days of ICA and CCTA
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Coronary CT angiography reader confidence by a 3 level visual scale assessed on CT images without and with Coronary Calcium Subtraction
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Within 90 days of ICA and CCTA
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Coronary stenosis severity in non-diagnostic or partially diagnostic segments by conventional CCTA
Tidsram: Within 90 days of ICA and CCTA
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In coronary segments deemed non-diagnostic or partially diagnostic due to calcification or coronary stents by conventional CCTA concordance of stenosis severity by Coronary Subtraction CT angiography and invasive quantitative coronary angiography is assessed
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Within 90 days of ICA and CCTA
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Coronary revascularization
Tidsram: Within 30 days after CCTA
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On a patient by patient level the ability of CCTA to predict need for coronary revascularization (PCI or CABG) is assessed using CCTA without and with coronary calcium subtraction
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Within 30 days after CCTA
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Klaus F Kofoed, MD, DmSc, Rigshospitalet, University of Copenhagen, Denmark
Publikationer och användbara länkar
Allmänna publikationer
- Fuchs A, Kuhl JT, Chen MY, Helqvist S, Razeto M, Arakita K, Steveson C, Arai AE, Kofoed KF. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography. J Cardiovasc Comput Tomogr. 2015 Sep-Oct;9(5):393-8. doi: 10.1016/j.jcct.2015.03.016. Epub 2015 Apr 16.
- Abdulla J, Pedersen KS, Budoff M, Kofoed KF. Influence of coronary calcification on the diagnostic accuracy of 64-slice computed tomography coronary angiography: a systematic review and meta-analysis. Int J Cardiovasc Imaging. 2012 Apr;28(4):943-53. doi: 10.1007/s10554-011-9902-6. Epub 2011 Jun 12.
- Tanaka R, Yoshioka K, Muranaka K, Chiba T, Ueda T, Sasaki T, Fusazaki T, Ehara S. Improved evaluation of calcified segments on coronary CT angiography: a feasibility study of coronary calcium subtraction. Int J Cardiovasc Imaging. 2013 Dec;29 Suppl 2:75-81. doi: 10.1007/s10554-013-0316-5. Epub 2013 Oct 25.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-3-2013-108
- ZIAHL006138 (U.S.S. NIH-anslag/kontrakt)
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