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Diagnostic Test

PC-CT Imaging for Coronary Artery Disease

N/A

Waitlist Available

Led By Cynthia McCollough, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Uncontrollable seizures within the last 3 months

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of ct exam, approximately 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether PCD-CT provides more information about coronary artery disease than regular CT imaging.

Who is the study for?

This trial is for patients who need a coronary artery cardiac CT scan and can consent to the study. They should not be pregnant, have severe kidney issues (eGFR ≤ 30), or known allergies to certain heart stress test drugs. It's not for hospitalized patients, those with serious heart rhythm problems, recent seizures, severe asthma/COPD, or a bad reaction to contrast dye before.

What is being tested?

The trial tests if using Photon Counting Detector CT (PCD-CT) scans after administering a drug that stresses the heart provides better information about suspected coronary artery disease severity compared to regular CT scans without the stress-inducing drug.

What are the potential side effects?

Possible side effects may include reactions related to the stress-inducing drug such as shortness of breath, chest pain, palpitations or irregular heartbeat. There might also be risks associated with contrast dye like allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had uncontrollable seizures in the last 3 months.

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I have had a severe reaction to contrast dye before.

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I have a serious heart rhythm problem but have a working pacemaker.

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I am currently experiencing heart-related chest pain.

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I am unable to sign a consent form.

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I am currently hospitalized or under care in the Emergency Department.

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I have irregular heartbeats such as atrial fibrillation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of ct exam, approximately 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of ct exam, approximately 1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of ct exam, approximately 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Clinical Nuclear Medicine or MRI Cardiac Stress Test CohortExperimental Treatment1 Intervention

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

Group II: Clinical Coronary CTA CohortExperimental Treatment1 Intervention

Subjects scheduled for a clinically indicated coronary CTA will receive a research contrast-enhanced coronary CT angiogram using photon-counting CT

0 / 7Eligibility criteria met