Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT05240807
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific exclusion criteria only for participation in the cardiac stress test arm of this study (requiring administration of Regadenoson):
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
Time frame: Through completion of CT exam, approximately 1 hour
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
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
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.
Time frame: Through completion of CT exam, approximately 1 hour
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.
Mayo Clinic
Other
Comprehensive Characterization of Coronary Atherosclerotic Disease Using Photon-counting Detector Dual-source CT and Its Impact on Patient Management
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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