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Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography (C-Sub320)
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02011061
First received: December 2, 2013
Last updated: November 5, 2016
Last verified: November 2016
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Purpose
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 |
|---|
| Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective International Study of Coronary Substraction Using 320 Row-detector CT |
Further study details as provided by Klaus Fuglsang Kofoed, Rigshospitalet, Denmark:
Primary Outcome Measures:
- 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:
- 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
- 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
- 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
| Enrollment: | 182 |
| Study Start Date: | October 2013 |
| Study Completion Date: | June 2016 |
| Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT02011061
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011061
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
Publications:
| 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 ) |
| Study First Received: | December 2, 2013 |
| Last Updated: | November 5, 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 |
ClinicalTrials.gov processed this record on July 27, 2017