Status:
RECRUITING
Clinical Impact of Cardiac Photon Counting CT
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-99 years
Phase:
NA
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 prov...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05240807
Start Date
August 24 2022
End Date
April 1 2026
Last Update
January 9 2026
Active Locations (1)
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1
Boleyn Andrist
Eyota, Minnesota, United States, 55934