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

Multidetector coronary computed tomography angiography (CTA) is a promising modality for widespread clinical application because of its noninvasive 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 article, 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 with 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. CT has the potential to assess both anatomy and physiology in a single imaging session. The co-primary aim 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 with (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.

Trial registration: ClinicalTrials.gov NCT00934037.

Figure 1

CORE320 study design. Workflow of patient enrollment, data acquisition, and data handling. Reproduced with permission from George, et al. AJR Am J Roentgenol 2011;197:829-37.

Figure 2

Depiction of one day and two day SPECT myocardial imaging protocols utilized in the CORE320 study. The rest/stress or stress/rest gated 99mTc SPECT imaging protocols are used with vasodilators (adenosine, dipyridamole, or regadenoson) or symptom limited exercise.

Figure 3

Depicts a CORE320 participant's entire imaging dataset. Panel A depicts a right coronary artery with a 100% occlusion using conventional coronary angiography. Panel B depicts an inferior and inferolateral wall, partially reversible perfusion defect on a SPECT scan. Panel C depicts a 100% occlusion in the right coronary artery on a CT coronary angiography. Panel D depicts an inferolateral wall perfusion defect on the CT myocardial perfusion image.