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RECRUITING

NCT05240807

Clinical Impact of Cardiac Photon Counting CT

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: Comprehensive Characterization of Coronary Atherosclerotic Disease Using Photon Counting- Detector Dual-source CT and Its Impact on Patient Management

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2022-08-24

Completion Date

2026-04-01

Last Updated

2026-01-09

Healthy Volunteers

Conditions

Coronary Artery Disease

Interventions

DIAGNOSTIC_TEST

Photon counting computed tomography (PC-CT)

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

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 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

Locations (1)

Boleyn Andrist

Eyota, Minnesota, United States