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Completed

NCT Number: NCT05240807

Clinical Impact of Cardiac Photon-Counting Detector CT

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for coronary artery cardiac CT imaging or nuclear medicine or MRI cardiac perfusion within the Department of Radiology or Cardiology.
  • Patients who are able and willing to sign the informed consent will be enrolled
  • Negative pregnancy test if subject is of child-bearing age (females of child-bearing potential will be screened for pregnancy using a urine pregnancy test, which will be administered by the unit study coordinator at no cost to the patient).

Exclusion criteria

  • Patients unable to provide written informed consent
  • Pregnancy
  • eGFR ≤ 30
  • History of prior moderate or severe contrast reaction includes: unresponsiveness, severe respiratory distress, convulsions, arrhythmia, cardiopulmonary distress, progressive angioedema, laryngeal edema, dyspnea, bronchospasm, symptomatic tachycardia, symptomatic bradycardia, hypotension, hypertensive crisis.
  • Any history of required premedication prior to iodinated contrast administration.
  • Patients that consent to participation but do not undergo their clinically-indicated, contrast-enhanced CT, or nuclear medicine or MR perfusion scanning for any reason (e.g., bad IV, infiltration, reaction, change in indication).
  • Patients experiencing atrial fibrillation, premature ventricular contractions or other heart rhythm abnormalities
  • Hospitalized patients or patients under care in the Emergency Department

Specific exclusion criteria only for participation in the cardiac stress test arm of this study (requiring administration of Regadenoson):

  • Anything by mouth within three hours of the examination
  • Known hypersensitivity to Regadenoson, Adenosine, or Dipyridamole.
  • Active ongoing wheezing or poorly controlled asthma or COPD (hospitalized within last month or receiving treatment for flair within last month).
  • Second (type I or II) or third degree atrioventricular (AV) block or sinus node dysfunction unless patient has functioning artificial pacemaker.
  • Ingested greater than 4 oz. of caffeine within the last 12 hours.
  • Currently experiencing unstable coronary syndrome.
  • Uncontrollable seizures within the last 3 months

Treatment and study plan

Photon-counting detector computed tomography (PCD-CT)

Diagnostic Test

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

Primary outcomes

  1. 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

    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.

  2. Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting Detector CT at Rest

    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.

Secondary outcomes

  1. Arm 1: Number of Participants With Decrease in Coronary Artery Disease-Reporting and Data System (CADRADS) Score

    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.

  2. Arm 2: Reader Sensitivity and Specificity to Myocardial Perfusion Defects Imaged by Photon-counting CT During Cardiac Stress

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

Comprehensive Characterization of Coronary Atherosclerotic Disease Using Photon-counting Detector Dual-source CT and Its Impact on Patient Management

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Jun 12, 2026

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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