PC-CT Imaging for Coronary Artery Disease

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

450 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Photon counting computed tomography (PC-CT) for coronary artery disease?

Photon counting computed tomography (PC-CT) is a new technology that shows promise in improving heart imaging by providing clearer images with less noise and lower radiation exposure. It can help doctors better detect and evaluate heart conditions like coronary artery calcifications and plaque, which are important for diagnosing coronary artery disease. ^{1 2 3 4 5}

Is photon-counting computed tomography (PC-CT) safe for humans?

Photon-counting computed tomography (PC-CT) is a new technology that offers several advantages over traditional CT scans, such as reduced radiation exposure and improved image quality, which can enhance safety in medical imaging. ^{1 2 3 6 7}

How is photon counting computed tomography (PC-CT) different from other treatments for coronary artery disease?

Photon counting computed tomography (PC-CT) is unique because it offers improved image quality with better spatial resolution and contrast, reduced radiation exposure, and the ability to differentiate materials more effectively than conventional CT scans. This makes it particularly useful for accurately assessing coronary artery conditions, such as plaque buildup and stent evaluation, which are challenging with traditional methods. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Cynthia McCollough, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Spectral photon-counting CT in cardiovascular imaging. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Photon-Counting Computed Tomography - Basic Principles, Potenzial Benefits, and Initial Clinical Experience. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiovascular Applications of Photon-Counting CT Technology: A Revolutionary New Diagnostic Step. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Dual-Source Photon-Counting Computed Tomography-Part I: Clinical Overview of Cardiac CT and Coronary CT Angiography Applications. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Photon Counting CT: Technical Principles, Clinical Applications, and Future Prospects. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Photon-counting computed tomography - clinical application in oncological, cardiovascular, and pediatric radiology. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Dual-Source Photon-Counting Computed Tomography-Part III: Clinical Overview of Vascular Applications beyond Cardiac and Neuro Imaging. [2023]