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Clinical Impact of Cardiac Photon Counting CT

RECRUITINGN/ASponsored by Mayo Clinic
Actively Recruiting
PhaseN/A
SponsorMayo Clinic
Started2022-08-24
Est. completion2026-03-31
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years – 99 YearsHealthy volunteers accepted
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

Conditions2

Coronary Artery DiseaseHeart Disease

Locations1 site

Boleyn Andrist
Eyota, Minnesota, 55934
Boleyn Andrist507-538-7752andrist.boleyn@mayo.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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