Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography
NCT ID: NCT02011061
Last Updated: 2021-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
182 participants
OBSERVATIONAL
2013-10-31
2016-06-30
Brief Summary
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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
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Scheduled for invasive coronary angiography
* Logistically possible to perform CCTA before invasive evaluation
Exclusion Criteria
* 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
55 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Rigshospitalet, Denmark
OTHER
Responsible Party
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Klaus Fuglsang Kofoed
associate professor
Principal Investigators
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Klaus F Kofoed, MD, DmSc
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, University of Copenhagen, Denmark
Locations
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National Heart, Lung and Blood Institute
Bethesda, Maryland, United States
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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H-3-2013-108
Identifier Type: -
Identifier Source: org_study_id
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