Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography

Coronary Artery Disease Clinical Trial

— C-Sub320  

Official title:

Prospective International Study of Coronary Substraction Using 320 Row-detector CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011061
• Other study ID #: H-3-2013-108
• Secondary ID: ZIAHL006138
• Status: Completed
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Denmark	Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen	Copenhagen
United States	National Heart, Lung and Blood Institute	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Denmark, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of Coronary Subtraction Coronary CT angiography	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.	Within 90 days of ICA and CCTA
Secondary	Coronary CT angiography reader confidence	Coronary CT angiography reader confidence by a 3 level visual scale assessed on CT images without and with Coronary Calcium Subtraction	Within 90 days of ICA and CCTA
Secondary	Coronary stenosis severity in non-diagnostic or partially diagnostic segments by conventional 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	Within 90 days of ICA and CCTA
Secondary	Coronary revascularization	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	Within 30 days after CCTA