Ultra-high-resolution CT vs. Conventional Angiography for Detecting Coronary Heart Disease

Study Summary

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 deter

Primary Outcome

The primary outcome was the patient-level diagnostic accuracy of ultra-high-resolution computed tomography (UHR-CT) compared with invasive coronary angiography (ICA) for identifying hemodynamically significant coronary artery disease (CAD), using quantitative flow ratio (QFR ≤0.80) as the reference standard. For each patient, the highest-grade stenosis across all coronary vessels determined by UHR-CT and ICA was used to classify the test result. Diagnostic accuracy was defined as the percentage

Conditions Studied

Interventions

• DIAGNOSTIC_TEST CT angiography
• DIAGNOSTIC_TEST Invasive coronary angiography

Study Locations (1)