Actively Recruiting
Ultra-High Resolution CT vs. Conventional CT for Detecting Obstructive Coronary Artery Disease The CORE-COMPARE Pilot Study
Led by Johns Hopkins University · Updated on 2026-04-13
140
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
C
Canon Medical Systems, USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in patients who may have obstructive coronary heart disease (CHD). The study aims to determine whether UHR-CT is better at identifying patients with significant artery narrowing, while considering concerns about higher radiation exposure and longer scan times with UHR-CT. This pilot study is important for deciding if UHR-CT should be used more widely in clinical practice. Participants will undergo CT scans using either the Ultra-High-Resolution CT scanner called Aquilion Precision or a conventional resolution CT scanner. The UHR-CT device provides very detailed images of heart anatomy, potentially resolving structures as small as 150 microns. The study uses these two imaging methods to compare their ability to detect obstructive coronary artery disease without subjecting patients to multiple scans. During the study, participants will receive CT angiography scans and have their images evaluated for artery narrowing greater than 70%, using catheterization as the gold standard for comparison. Researchers will also assess diagnostic confidence, agreement between observers, and analyze vascular features including plaque and surrounding tissue. The study will monitor participants for up to 24 months to collect these outcomes. Participants will be monitored for safety and the results will inform the potential advantages of UHR-CT in heart disease diagnosis.
CONDITIONS
Brief Title
CORE-COMPARE Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 21 to 85 years
- Clinical history suggesting coronary heart disease and referred for CT angiography by a cardiologist
- Women of childbearing potential must have a negative pregnancy test within 24 hours before the CT scan
- Ability to understand and willing to sign the informed consent form
You will not qualify if you...
- Known allergy to iodinated contrast media
- History of multiple myeloma or previous organ transplantation
- Elevated serum creatinine greater than 1.5 mg/dl or creatinine clearance less than 60 ml/min
- Atrial fibrillation, uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree)
- Severe symptomatic heart failure (NYHA Class III or IV)
- Known or suspected moderate or severe aortic stenosis
- Prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
- Suspected acute coronary syndrome
- Any other condition that the investigator considers problematic for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo CT scans using either the Ultra-High Resolution CT or Conventional Resolution CT imaging modalities to detect obstructive coronary artery disease.
1 imaging visit (in-person)
Duration - Up to 24 months
Participants are observed for up to 24 months to assess agreement between imaging results and clinical outcomes related to coronary artery disease.
Follow-up visits as needed for up to 24 months
Trial Site Locations
Total: 1 location
1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
J
Joao Lima, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here