Diagnostic performance of combined noninvasive coronary angiography and myocardial perfusion imaging using 320 row detector computed tomography: design and implementation of the CORE320 multicenter, multinational diagnostic study

Abstract

Multi-detector coronary computed tomography angiography (CTA) is a promising modality for widespread clinical application because of its non-invasive nature and high diagnostic accuracy as found in previous studies using 64 to 320 simultaneous detector rows. It is, however, limited in its ability to detect myocardial ischemia. In this manuscript we describe the design of the CORE320 study (“Combined Coronary Atherosclerosis and Myocardial Perfusion Evaluation Using 320 Detector Row Computed Tomography”). This prospective, multicenter, multinational study is unique in that it is designed to assess the diagnostic performance of combined 320-row CTA and myocardial CT perfusion imaging (CTP) in comparison to the combination of invasive coronary angiography and single photon emission computed tomography myocardial perfusion imaging (SPECT-MPI). The trial is being performed at 16 medical centers located in 8 countries worldwide. Computed tomography has the potential to assess both anatomy and physiology in a single imaging session. The co-primary aims of the CORE320 study is to define the per-patient diagnostic accuracy of the combination of coronary CTA and myocardial CTP to detect physiologically significant coronary artery disease compared to 1) the combination of conventional coronary angiography and SPECT-MPI and 2) conventional coronary angiography alone. If successful, the technology could revolutionize the management of patients with symptomatic CAD.

Aligning Coronary Anatomy and Myocardial Perfusion Territories

“…17 The primary diagnostic parameters are the areas under the receiver operating characteristic curve, sensitivity, and specificity of combined multidetector CT coronary angiography (CTA) and myocardial CT perfusion imaging (CTP) for identifying coronary artery stenosis >50% with a corresponding myocardial perfusion defects in patients with suspected coronary artery disease compared with CCA and single-photon emission tomography myocardial perfusion imaging (SPECT). Because the primary aim of the CORE320 study is to detect obstructive atherosclerosis causing corresponding myocardial perfusion deficits, abnormal myocardial territories require anatomic coregistration with the culprit vessel.…”

Computed Tomographic Perfusion Improves Diagnostic Power of Coronary Computed Tomographic Angiography in Women

“…The primary objectives of the CORE320 trial were to assess the accuracy of coronary CTA and CTP in identifying coronary stenosis (≥50%) by ICA with a corresponding myocardial perfusion defect on SPECT. 20 The study design has been previously published in detail. 20 In short, the study enrolled patients 45 to 85 years of age with suspected or known CAD referred for ICA.…”

“…20 The study design has been previously published in detail. 20 In short, the study enrolled patients 45 to 85 years of age with suspected or known CAD referred for ICA. All patients had a SPECT/myocardial perfusion imaging (performed clinically or as part of research protocol), ICA, adenosine stress CTP, and coronary CTA performed in a CORE320-validated laboratory.…”

“…All patients had a SPECT/myocardial perfusion imaging (performed clinically or as part of research protocol), ICA, adenosine stress CTP, and coronary CTA performed in a CORE320-validated laboratory. 20 Women of childbearing potential had a negative pregnancy test within 24 hours before computed tomography. 20 Computed tomographic image acquisition has been previously described in detail.…”

“…20 Women of childbearing potential had a negative pregnancy test within 24 hours before computed tomography. 20 Computed tomographic image acquisition has been previously described in detail. 15,[20][21][22] All CTA and CTP images were reconstructed, processed, and interpreted by 2 blinded core laboratories.…”