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Clinical Impact of Cardiac Photon Counting CT

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photon counting computed tomography (PC-CT)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary CT Angiography, Cardiac Stress Imaging, Photon Counting CT, Cardiac CT

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 with coronary artery bypass grafts
  • 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

Sites / Locations

  • Boleyn AndristRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clinical Coronary CTA Cohort

Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort

Arm Description

Subjects scheduled for a clinically indicated coronary CTA will receive a research contrast-enhanced coronary CT angiogram using photon-counting 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 CT at rest and after administration of a cardiac stress agent

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2022
Last Updated
November 7, 2022
Sponsor
Mayo Clinic
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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1. Study Identification

Unique Protocol Identification Number
NCT05240807
Brief Title
Clinical Impact of Cardiac Photon Counting CT
Official Title
Comprehensive Characterization of Coronary Atherosclerotic Disease Using Photon Counting- Detector Dual-source CT and Its Impact on Patient Management
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary CT Angiography, Cardiac Stress Imaging, Photon Counting CT, Cardiac CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical Coronary CTA Cohort
Arm Type
Experimental
Arm Description
Subjects scheduled for a clinically indicated coronary CTA will receive a research contrast-enhanced coronary CT angiogram using photon-counting CT
Arm Title
Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Photon counting computed tomography (PC-CT)
Intervention Description
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 Outcome Measure Information:
Title
Change in disease status or post-exam recommendations
Description
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.
Time Frame
Through completion of CT exam, approximately 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 with coronary artery bypass grafts 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia McCollough, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boleyn Andrist
City
Eyota
State/Province
Minnesota
ZIP/Postal Code
55934
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boleyn Andrist
Phone
507-538-7752
Email
andrist.boleyn@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ryan Jacobson
Phone
5075387344
Email
Jacobson.ryan1@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Clinical Impact of Cardiac Photon Counting CT

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