Cardiac catheterization with invasive coronary angiography is the gold standard for determining the presence or absence of significant coronary heart disease (CHD). However, cardiac catheterization is costly and, as an invasive procedure, it is associated with some risk of adverse events, rarely even stroke, myocardial infarction, or death. Recent advances in multi-detector computed tomography angiography (CTA) have allowed rapid, noninvasive coronary artery imaging in patients with suspected CHD. CTA generally yields high accuracy for identifying patients with CHD when compared to cardiac catheterization. However, diagnostic accuracy is reduced in the setting of severe coronary artery calcification and coronary stents due to its inferior spatial resolution compared to cardiac catheterization. Because high-risk patients often have severe coronary calcification or stents, the application of CTA has been particularly limited in this important patient group. Recently, an ultrahigh-resolution CT scanner was released which has shown promise to overcome the limitation of conventional CTA in the setting of severe coronary artery calcification or stents. This ultrahigh-resolution "precision" CT scanner (UHR-CT) contains detector rows with half the width than currently available systems (0.25 mm vs. 0.5 mm) resulting in approximately twice the spatial resolution. The purpose of this investigation is to test the hypothesis that high-resolution CTA is not inferior to the current standard of cardiac catheterization for identifying significant CHD in patients with high-risk characteristics, including severe coronary artery calcification and coronary stents. The investigators propose to enroll 50 patients over 24-30 months in this investigation as part of a multicenter study. Patients referred for cardiac catheterization with known CHD and suspected obstructive coronary artery stenosis will be included. All patients will undergo both cardiac catheterization and UHR-CT for determining significant CHD as defined by coronary functional assessment. The primary end point will be the diagnostic accuracy by area-under-curve (AUC) method for identifying patients with hemodynamically significant CHD.
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of Correctly Classified Coronary Artery Disease Patients (True Positives and True Negatives)
Timeframe: Up to 90 days