Ultra-high-resolution CT vs. invasive angiography for detecting hemodynamically significant coronary artery disease: Rationale and methods of the CORE-PRECISION multicenter study

J Cardiovasc Comput Tomogr. 2024 Sep-Oct;18(5):444-449. doi: 10.1016/j.jcct.2024.04.012. Epub 2024 Apr 25.

Abstract

Background: Direct coronary arterial evaluation via computed tomography (CT) angiography is the most accurate noninvasive test for the diagnosis of coronary artery disease (CAD). However, diagnostic accuracy is limited in the setting of severe coronary calcification or stents. Ultra-high-resolution CT (UHR-CT) may overcome this limitation, but no rigorous study has tested this hypothesis.

Methods: The CORE-PRECISION is an international, multicenter, prospective diagnostic accuracy study testing the non-inferiority of UHR-CT compared to invasive coronary angiography (ICA) for identifying patients with hemodynamically significant CAD. The study will enroll 150 patients with history of CAD, defined as prior documentation of lumen obstruction, stenting, or a calcium score ≥400, who will undergo UHR-CT before clinically prompted ICA. Assessment of hemodynamically significant CAD by UHR-CT and ICA will follow clinical standards. The reference standard will be the quantitative flow ratio (QFR) with <0.8 defined as abnormal. All data will be analyzed in independent core laboratories.

Results: The primary outcome will be the comparative diagnostic accuracy of UHR-CT vs. ICA for detecting hemodynamically significant CAD on a patient level. Secondary analyses will focus on vessel level diagnostic accuracy, quantitative stenosis analysis, automated contour detection, in-depth plaque analysis, and others.

Conclusion: CORE-PRECISION aims to investigate if UHR-CT is non-inferior to ICA for detecting hemodynamically significant CAD in high-risk patients, including those with severe coronary calcification or stents. We anticipate this study to provide valuable insights into the utility of UHR-CT in this challenging population and for its potential to establish a new standard for CAD assessment.

Keywords: Coronary artery disease; Coronary atherosclerosis; Coronary computed tomography angiography; Spatial resolution; Ultra-high-resolution CT.

Publication types

  • Clinical Trial Protocol
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Computed Tomography Angiography*
  • Coronary Angiography*
  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / physiopathology
  • Coronary Circulation
  • Coronary Vessels* / diagnostic imaging
  • Coronary Vessels* / physiopathology
  • Europe
  • Female
  • Hemodynamics*
  • Humans
  • Male
  • Multicenter Studies as Topic
  • Predictive Value of Tests*
  • Prospective Studies
  • Reproducibility of Results
  • Severity of Illness Index*
  • United States
  • Vascular Calcification / diagnostic imaging
  • Vascular Calcification / physiopathology