Coronary Artery DiseaseNCT05240807

Clinical Impact of Cardiac Photon-Counting Detector CT

A study testing Photon-counting detector computed tomography (PCD-CT) in people with Coronary Artery Disease, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Coronary Artery Disease
What is being tested?: Photon-counting detector computed tomography (PCD-CT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 1 siteUnited States
Study dates: 24 Aug 2022to 19 Mar 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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).

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

Read the 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.

Conditions: Coronary Artery Disease
Being tested: Photon-counting detector computed tomography (PCD-CT)
Keywords: Coronary CT Angiography, Cardiac Stress Imaging, Photon Counting CT, Cardiac CT
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05240807
Study group	Role	What they receive
Clinical Coronary CTA Cohort	Experimental	Subjects scheduled for a clinically indicated coronary CT angiogram will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT. Receives: Diagnostic Test: Photon-counting detector computed tomography (PCD-CT)
Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort	Experimental	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 detector CT at rest and after administration of a cardiac stress agent. Receives: Diagnostic Test: Photon-counting detector computed tomography (PCD-CT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Through completion of CT exam, approximately 1 hour

Secondary outcomes (2)

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.
Measured: 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.
Measured: Through completion of CT exam, approximately 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 202219 Mar 2026

First posted15 Feb 2022
Study start24 Aug 2022
Primary completion19 Feb 2026
Study completion19 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05240807
Sponsor's protocol ID: 21-004933
Other IDs: R01EB028590
Status last verified: Jun 2026
First submitted: 14 Jan 2022
Last updated: 12 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comprehensive Characterization of Coronary Atherosclerotic Disease Using Photon-counting Detector Dual-source CT and Its Impact on Patient Management
ClinicalTrials.gov ID: NCT05240807
Acronym / sponsor ID: 21-004933
Conditions: Coronary Artery Disease
Keywords: Coronary CT Angiography, Cardiac Stress Imaging, Photon Counting CT, Cardiac CT
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Study start: 24 Aug 2022 (actual)
Primary completion: 19 Feb 2026 (actual)
Study completion: 19 Mar 2026 (actual)
First posted: 15 Feb 2022 (actual)
Results: Posted 12 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Clinical Coronary CTA Cohort	Experimental	Diagnostic Test: Photon-counting detector computed tomography (PCD-CT)Subjects scheduled for a clinically indicated coronary CT angiogram will receive a research contrast-enhanced coronary CT angiogram using photon-counting detector CT.
Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort	Experimental	Diagnostic Test: Photon-counting detector computed tomography (PCD-CT)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 detector CT at rest and after administration of a cardiac stress agent.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Photon-counting detector computed tomography (PCD-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	Diagnostic test	Clinical Coronary CTA Cohort, Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort

Primary outcome

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.
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.

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 12 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clinical Coronary CTA Cohort	235	235
Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort	11	11

Primary outcome: 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. Median (95% Confidence Interval). Unit: Percent

Measure	Clinical Coronary CTA Cohort n = 139	Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort n = 0
Arm 1a (pre-multi-energy scanner update)	-6.7 (-8.0 to -5.5)	–
Arm 1b (post-multi-energy scanner update)	-4.16 (-7.56 to -1.27)	–

Clinical Coronary CTA Cohort: p <0.008, Wilcoxon (Mann-Whitney)

Population analysed: To compare PAS, PCD and EID-CT scans are needed so only arm 1 participants were analyzed in this measure. 235 participants were enrolled in arm 1, however 139 participants were analyzed as this outcome measure only pertains to the subset of patients with evaluable, calcified stenosis (i.e., low motion artifact, visible in both scans). Arm 1 was split into and analyzed in 2 groups due to a change in PCD-CT technology during recruitment (multi-energy ultra-high resolution update).

Primary outcome: 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. Number. Unit: Percent

Measure	Clinical Coronary CTA Cohort n = 0	Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort n = 11
Sensitivity	–	50
Specificity	–	80

Population analysed: Perfusion defect analysis requires both nuclear medicine stress tests and photon-counting detector CT. Therefore, only arm 2 of the trial is included in this analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent through completion of PCD-CT research scan, approximately 1 hour.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clinical Coronary CTA Cohort	0 of 235 (0%)	0 of 235 (0%)	0 of 235
Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Limitations and caveats (from the sponsor): In arm 1, this study only considers calcified stenosis and makes no claims as to the effect of PCD-CT (versus EID-CT) on non-calcified coronary plaque. Arm 2 recruitment was severely limited because many participants did not want to take a cardiac stress agent. This resulted in a low number of participants in arm 2. Therefore, only descriptive statistics are provided for arm 2.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia McCollough, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Photon-counting detector computed tomography (PCD-CT) in people with Coronary Artery Disease, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05240807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.