Clinical Impact of Cardiac Photon Counting CT

Overview

About this study

This study will focus on demonstrating the benefits of Photon Counting Detector CT Scan (PCD-CT) for clinical indications and findings are expected to benefit the diagnosis and characterization of Coronary Artery Disease (CAD) and myocardial perfusion defects.

Specific Aim:  

In patients, measure the clinical impact of cardiac PCD-CT on patient diagnosis and management

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Cynthia McCollough, Ph.D.

Open for enrollment

Contact information:

Boleyn Andrist CCRP

(507) 538-7344

Andrist.Boleyn@mayo.edu

More information

Publications

Publications are currently not available