Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | June 2016 |
| Contact: | Klaus F Kofoed, MD, DmSc |
| Email: | kkofoed@dadlnet.dk |
| Phone: | +45 35458569 |
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
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
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.
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.
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
We found this trial at
2
sites
Copenhagen,
Phone: +45 35458569
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Bethesda, Maryland 20892
Principal Investigator: Marcus Chen, MD
Phone: 301-496-0211
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