Clinical Impact of Cardiac Photon Counting CT

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

The purpose of this research trial is to determine whether images taken using a Photon Counting Detector CT scanner (PCD-CT) after the patient has received a drug that makes the heart work harder provide clinically important information about the severity of suspected coronary artery disease compared to CT imaging performed without using the drug that causes the heart to work harder.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Photon counting computed tomography (PC-CT)

Detailed Description

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
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Eyota, Minnesota, United States, 55934
      • Boleyn Andrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical Coronary CTA Cohort; Subjects scheduled for a clinically indicated coronary CTA will receive a research contrast-enhanced coronary CT angiogram using photon-counting CT	Diagnostic test: Photon counting computed tomography (PC-CT); 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
Experimental: Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort; Subjects scheduled for a clinically indicated nuclear medicine or MRI cardiac stress test will receive a research contrast-enhanced coronary CT angiogram using photon-counting CT at rest and after administration of a cardiac stress agent	Diagnostic test: Photon counting computed tomography (PC-CT); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in disease status or post-exam recommendations	A sub-specialty trained cardiac radiologist and a sub-specialty trained cardiologist will compare qualitative and quantitative results from the photon counting CT scans to the clinically ordered CT, MRI, or nuclear medicine scan. Clinically important differences in findings and recommendations will be recorded to assess the overall clinical impact of using photon-counting CT to assess patients with potential coronary artery disease, especially patients with heavily calcified, stented, or high-risk plaques, or having myocardial perfusion defects. Our premise is that the established benefits of PCD-CT, used with a dual-source geometry and advanced noise reduction and material decomposition algorithms, will yield clinically important differences in imaging findings that will impact patient management decisions.	Through completion of CT exam, approximately 1 day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Cynthia McCollough, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Actual): February 19, 2026
• Study Completion (Actual): March 19, 2026

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac CT; Photon Counting CT; Coronary CT Angiography; Cardiac Stress Imaging
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 21-004933; R01EB028590-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No