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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of ct exam, approximately 1 day
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
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
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,334 Total Patients Enrolled
28 Trials studying Coronary Artery Disease
26,840 Patients Enrolled for Coronary Artery Disease
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
89 Previous Clinical Trials
19,334 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
338 Patients Enrolled for Coronary Artery Disease
Cynthia McCollough, PhDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to Regadenoson, Adenosine, or Dipyridamole.I haven't eaten or drunk anything for 3 hours before the cardiac stress test.I am willing and able to sign the informed consent.I have not had uncontrollable seizures in the last 3 months.You have needed to take medicine before getting a certain kind of contrast dye in the past.I have severe asthma or COPD, with recent hospital visits or treatment.I am referred for a heart scan using CT, MRI, or nuclear medicine.Your kidney function is very low, with an eGFR of 30 or less.I have had a severe reaction to contrast dye before.I have a serious heart rhythm problem but have a working pacemaker.You have had more than a small coffee cup's worth of caffeine in the last 12 hours.I am currently experiencing heart-related chest pain.You agree to take part in the study but don't get the contrast-enhanced CT, nuclear medicine, or MR perfusion scanning that your doctor recommends for any reason.I am not pregnant or have a negative pregnancy test result.I am unable to sign a consent form.I am currently hospitalized or under care in the Emergency Department.I have irregular heartbeats such as atrial fibrillation.
Research Study Groups:
This trial has the following groups:- Group 1: Clinical Coronary CTA Cohort
- Group 2: Clinical Nuclear Medicine or MRI Cardiac Stress Test Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available for this clinical research project?
"Correct. According to clinicaltrials.gov, this medical study commenced on August 24th 2022 and has recently been updated on November 7th 2022. The objective is to enrol a total of 450 patients from two sites for participation in the trial."
Answered by AI
Is this research limited to those aged 50 and over, or can younger individuals participate?
"This medical trial is recruiting adults aged between 18 and 99 years old."
Answered by AI
What is the current enrollment cap for this experiment?
"Affirmative. As per clinicaltrials.gov, this medical experiment is actively recruiting as of November 7th 2022 with the initial posting being on August 24th 2022. 450 patients must be enrolled at two different locations to meet the trial's requirements."
Answered by AI
How can I get involved in this research initiative?
"Applicants for this clinical trial must possess coronary artery disease and be between 18-99 years old. The research team is accepting up to 450 participants into the study."
Answered by AI
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