The purpose of this research trial is to determine whether images taken using a Photon Counting Detector CT scanner (PCD-CT) provide clinically important information about the severity of suspected coronary artery disease and perfusion defects compared to traditional Energy Integrating Detector CT (EID-CT) and nuclear medicine cardiac stress tests.
This study will focus on demonstrating the benefits of PCD-CT for clinical indications and findings where the improved spatial and temporal resolution, decreased quantum and electronic noise, improved spectral imaging capabilities, and increased iodine signal are expected to benefit the diagnosis and characterization of CAD and myocardial perfusion defects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
276
Cardiac CT imaging will be performed using a newly developed CT scanner that uses photon-counting detectors and the results compared to those from conventional CT, MRI, or nuclear medicine imaging systems
Mayo Clinic
Rochester, Minnesota, United States
Arm 1: Change in Clinical Coronary Artery Disease Status Measured in Photon-counting Detector CT Relative to Clinical CT as Measured by Percent Area Stenosis
Percent area stenosis (PAS) measures coronary artery stenosis (blockage) and is defined as the vessel's cross-sectional area in the region of highest stenosis (i.e., most closed) divided by the healthy vessel's cross-sectional area. PAS can range from 0% to 100% with higher percentages indicating worse stenosis. In arm 1, PAS was measured at the site of worst stenosis in each coronary vessel or patient using validated commercial software. For each stenosis, PAS was measured at the same location in the photon-counting detector CT (PCD-CT) angiography scan and in the clinical CT angiography scan (EID-CT). These values were subtracted to get a change in PAS between the clinical EID-CT scan and the PCD-CT scan for each stenosis. Change in PAS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update.
Time frame: Through completion of CT exam, approximately 1 hour
Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting Detector CT at Rest
Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector (PCD) CT divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken when the patient was at rest.
Time frame: Through completion of CT exam, approximately 1 hour
Arm 1: Number of Participants With Decrease in Coronary Artery Disease-Reporting and Data System (CADRADS) Score
Coronary Artery Disease-Reporting and Data System (CADRADS) score is a value assigned to each patient based on the patient's highest percent diameter stenosis (PDS) with higher scores indicating worse stenosis. PDS is defined as the diameter of the stenosed (blocked) coronary vessel divided by the diameter of the healthy vessel. A CADRADs score of 0-5 is assigned to the following PDS values, respectively: 0%, 1-24%, 25-49%, 50-70%, 70-99%, and 100%. A CADRAD score was calculated for each patient in both EID-CT and PCD-CT scans based on the respective PDS for the same lesion. The number of patients whose CADRADS decreased in PCD-CT relative to EID-CT (e.g. 2 on PCD-CT, 3 on EID-CT) is reported below. Change in CADRADS impacts patient management. During recruitment, the PCD-CT scanner had a multi-energy ultra-high resolution update allowing a new scan mode that collected x-ray energy data. This mode was used for all patients recruited after the update.
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Time frame: Through completion of CT exam, approximately 1 hour
Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting CT During Cardiac Stress
Sensitivity was calculated as the number of patients correctly identified by the reader as having perfusion defects on photon-counting detector CT (PCD-CT) divided by the total number of patients with perfusion defects. Specificity was calculated as the number of patients correctly identified by the reader as not having perfusion defects on PCD-CT divided by the total number of patients without perfusion defects. Sensitivity and specificity can range between 0 and 100%. All analyzed images were taken after the patient was administered a pharmacological cardiac stress agent to increase heart rate.
Time frame: Through completion of CT exam, approximately 1 hour