PC-CT Imaging for Coronary Artery Disease

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Regadenoson, Adenosine, Dipyridamole

Disqualifiers: Pregnancy, eGFR ≤ 30, Heart rhythm abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for examining the heart using advanced imaging technology. It seeks to determine if a special CT scanner, called Photon Counting Detector CT, can provide better insights into coronary artery disease when a drug induces stress on the heart. The trial includes two groups: one for individuals receiving a regular coronary CT scan and another for those undergoing a stress test with a drug to stress the heart. Ideal candidates are those already scheduled for a heart CT or stress test and who can consent to participate. As an unphased trial, this study offers a unique opportunity to contribute to cutting-edge research in heart imaging.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are participating in the cardiac stress test part of the study, you should avoid caffeine and certain medications that might interact with the stress test drug.

What prior data suggests that this imaging technique is safe for coronary artery disease patients?

Research shows that photon counting computed tomography (PC-CT) is generally well-tolerated by patients. Studies have found it to be very accurate in diagnosing heart disease, demonstrating its effectiveness and reliability. It provides clearer images with less radiation than traditional CT scans, enhancing patient safety.

No specific reports of negative side effects have been directly linked to PC-CT in the available studies. Its improved imaging can lead to quicker and more accurate diagnoses without additional risk. Although PC-CT is not yet widely available, its current use in medical settings suggests it is safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about photon counting computed tomography (PC-CT) for coronary artery disease because it offers a cutting-edge imaging technique that could enhance diagnostic clarity. Unlike traditional CT scans, PC-CT captures images with higher resolution and less noise, potentially leading to more accurate assessments of coronary arteries. Moreover, PC-CT can differentiate between materials more effectively, which may improve the detection of plaque build-up in arteries. This could lead to earlier and more precise intervention, setting it apart from the current standard imaging methods like traditional CT and MRI scans.

What evidence suggests that this imaging technique is effective for coronary artery disease?

Research has shown that a new type of CT scan, photon-counting computed tomography (PC-CT), can greatly improve heart imaging. In this trial, participants will divide into two cohorts: one will receive a research contrast-enhanced coronary CT angiogram using PC-CT during a clinically indicated coronary CTA, and the other will receive the same PC-CT angiogram at rest and after a cardiac stress agent during a clinically indicated nuclear medicine or MRI cardiac stress test. Studies indicate that PC-CT helps doctors see inside blood vessels, identify plaque buildup, and examine heart tissue. It provides clearer images with less background noise and uses a lower radiation dose than traditional CT scans. This means PC-CT can give more detailed and accurate information about heart disease, aiding doctors in making better treatment decisions. Overall, PC-CT appears promising for improving the diagnosis and management of heart conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Cynthia McCollough, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients who need a coronary artery cardiac CT scan and can consent to the study. They should not be pregnant, have severe kidney issues (eGFR ≤ 30), or known allergies to certain heart stress test drugs. It's not for hospitalized patients, those with serious heart rhythm problems, recent seizures, severe asthma/COPD, or a bad reaction to contrast dye before.

Inclusion Criteria

I am willing and able to sign the informed consent.

I am referred for a heart scan using CT, MRI, or nuclear medicine.

I am not pregnant or have a negative pregnancy test result.

Exclusion Criteria

You are allergic to Regadenoson, Adenosine, or Dipyridamole.

I haven't eaten or drunk anything for 3 hours before the cardiac stress test.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo a photon-counting CT scan with and without a cardiac stress agent

1 day

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Photon counting computed tomography (PC-CT)

Trial Overview The trial tests if using Photon Counting Detector CT (PCD-CT) scans after administering a drug that stresses the heart provides better information about suspected coronary artery disease severity compared to regular CT scans without the stress-inducing drug.

How Is the Trial Designed?

Group I: Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort Experimental Treatment 1 Intervention

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

Group II: Clinical Coronary CTA Cohort Experimental Treatment 1 Intervention

Subjects scheduled for a clinically indicated coronary CTA will receive a research contrast-enhanced coronary CT angiogram using photon-counting CT

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Published Research Related to This Trial

Photon-counting computed tomography (PCCT) offers significant improvements over traditional CT by counting individual photons, leading to enhanced spatial resolution and reduced image noise, which can improve diagnostic accuracy.

PCCT has the potential to reduce radiation doses and minimize beam hardening artifacts, making it a safer and more effective imaging option in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photon-Counting Computed Tomography - Basic Principles, Potenzial Benefits, and Initial Clinical Experience. Stein, T., Rau, A., Russe, MF., et al.[2023]

Photon-counting detector computed tomography (PCD-CT) allows for counting individual photons, leading to improved spatial resolution and reduced image noise compared to traditional CT, which enhances image quality.

PCD-CT offers significant clinical benefits, including reduced radiation doses and fewer beam hardening artifacts, particularly benefiting vulnerable patient groups such as those in oncology, cardiology, and pediatrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photon-counting computed tomography - clinical application in oncological, cardiovascular, and pediatric radiology. Hagen, F., Soschynski, M., Weis, M., et al.[2023]

Photon-counting computed tomography (PCCT) uses advanced detectors to convert X-ray photons into electrical signals, leading to higher spatial resolution and improved imaging quality.

PCCT offers significant benefits such as reduced radiation doses, fewer artifacts, and the ability to perform multienergy imaging, making it a promising advancement in clinical imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photon Counting CT: Technical Principles, Clinical Applications, and Future Prospects. Wu, Y., Ye, Z., Chen, J., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40540955/

Cost-effectiveness of photon counting detector CT for ... Purpose: The purpose of this study was to evaluate the cost-effectiveness of photon-counting detector computed tomography (PCD-CT) compared to ...

2. journalofcardiovascularct.com journalofcardiovascularct.com/article/S1934-5925(24)00461-1/fulltext

Cost-effectiveness of ultrahigh-resolution photon-counting ... Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease. J ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1936878X25000269

Benchmarking Photon-Counting Computed Tomography ... The authors evaluate the ability of PCCTA to quantitatively assess coronary luminal stenosis in the presence and absence of calcification.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11622532/

A Review of Photon-Counting Computed Tomography ... found that PCCT systems achieved excellent spatial resolution and substantial reductions in noise (up to 47%) and dose (up to 30%) compared to ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1936878X25004759

Photon-Counting Computed Tomography in Cardiac Imaging Available data suggest that PCCT enhances coronary lumen evaluation, plaque characterization, and myocardial tissue assessment, with reduced ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X25003316

Cost-effectiveness of photon counting detector CT for ... The purpose of this study was to evaluate the cost-effectiveness of photon-counting detector computed tomography (PCD-CT) compared to energy-integrating ...

7. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.223305

Accuracy of Ultrahigh-Resolution Photon-counting CT for ... UHR photon-counting CCTA provided high diagnostic accuracy in the detection of CAD in a high-risk population, including subjects with severe coronary ...

8. cdt.amegroups.org cdt.amegroups.org/article/view/127186/html

Technical principles, benefits, challenges, and applications of ... The main advantages of PCCT over traditional CT are enhanced spatial resolution, improved signal and contrast characteristics, diminished electronic noise and ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11631184/

Ultra-low-dose coronary computed tomography ... Coronary CT angiography (CCTA) can rule out coronary artery disease (CAD) with a high negative predictive value and provides significant prognostic information, ...