Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography (C-Sub320)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease
Coronary Artery Disease

Detailed Description:

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	182 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Prospective International Study of Coronary Substraction Using 320 Row-detector CT
Study Start Date :	October 2013
Actual Primary Completion Date :	June 2016
Actual Study Completion Date :	June 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Diagnostic accuracy of Coronary Subtraction Coronary CT angiography [ Time Frame: Within 90 days of ICA and CCTA ]
   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.

Secondary Outcome Measures :

1. Coronary CT angiography reader confidence [ Time Frame: Within 90 days of ICA and CCTA ]
   Coronary CT angiography reader confidence by a 3 level visual scale assessed on CT images without and with Coronary Calcium Subtraction
2. Coronary stenosis severity in non-diagnostic or partially diagnostic segments by conventional CCTA [ Time Frame: Within 90 days of ICA and CCTA ]
   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
3. Coronary revascularization [ Time Frame: Within 30 days after CCTA ]
   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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	55 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients (N=200) referred for in hospital invasive coronary evaluation

Criteria

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

Contacts and Locations

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Locations

United States, Maryland
National Heart, Lung and Blood Institute
Bethesda, Maryland, United States, 20892
Denmark
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Klaus F Kofoed, MD, DmSc	Rigshospitalet, University of Copenhagen, Denmark

More Information

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Publications:

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. Review.

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, Kühl 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.

Responsible Party:	Klaus Fuglsang Kofoed, associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT02011061 History of Changes
Other Study ID Numbers:	H-3-2013-108; ZIAHL006138 ( U.S. NIH Grant/Contract )
First Posted:	December 13, 2013
Last Update Posted:	November 8, 2016
Last Verified:	November 2016

Keywords provided by Klaus Fuglsang Kofoed, Rigshospitalet, Denmark:

Multidetector Computed Tomography; Coronary Stenosis; Coronary Artery Disease; Angina Pectoris

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases	Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases