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Completed

NCT Number: NCT02011061

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

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

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: C-Sub320

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2013
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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