- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Copenhagen, Danimarca, 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, Stati Uniti, 20892
- National Heart, Lung and Blood Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Diagnostic accuracy of Coronary Subtraction Coronary CT angiography
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Coronary CT angiography reader confidence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Klaus F Kofoed, MD, DmSc, Rigshospitalet, University of Copenhagen, Denmark
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Completamento primario (Effettivo)
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Date di iscrizione allo studio
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Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- H-3-2013-108
- ZIAHL006138 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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