NCT06170541 · Johns Hopkins University
CORE-COMPARE Pilot Study
What this study is about
The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times.
View original scientific description
The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times. The availability of technology to reconstruct conventional resolution (CR) simulation images from the raw CT acquisition data acquired on the UHR-CT scanner offers a unique platform to study this question without subjecting individuals to two different scans. The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is superior to conventional resolution CT for identifying patients with obstructive CHD.
Interventions
DEVICE
Aquilion Precision
Ultra-High Resolution CT (UHR CT) capable of resolving anatomy as small as 150 microns, providing CT image quality with resolution typically seen only in cath labs. The UHR detector is newly designed to provide more than twice the resolution when compared with today's CT technology, with an all-new detector as well as tube, gantry and reconstruction technologies.
DEVICE
Conventional Computed Tomography
Conventional reconstruction Computed Tomography (CT) represents a pivotal approach in medical imaging.
Primary outcome measures
agreement between the number of patients with >70% stenosis detected by ultra-high-resolution tomography compared to conventional tomography, with catheterization considered as the gold standard.
Time frame: Up to 24 Months
The ultra-high-resolution CT images (UHRCT) and the reconstructed conventional CT resolution images (CRCT) will be independently reviewed by two observers (with a 60-day washout period between both images). The stenoses will be classified according to the Society of Cardiovascular Computed Tomography (SCCT) classification system (\<25%, 25-49%, 50-69%, 70-99%, and occluded). Patients with stenosis greater than 70% will be flagged. The primary outcome will be assessed for patients that underwent a clinically indicated invasive angiography (ICA). To compare agreement between UHRCT and CRCT studies while using ICA as the gold-standard, a concordance meta-analysis will be employed. This involves evaluating the agreement measures from each study, standardizing the results, and then comparing the concordance results of the two studies with the third study, considered the gold standard.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients aged 21-85 years
- Clinical history suggestive of CHD who are referred by their primary cardiologist for further evaluation via Computed tomography angiography (CTA) will be asked to participate.
- Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA.
- Ability to understand and willingness to sign the Informed Consent Form.
Exclusion criteria
- Known allergy to iodinated contrast media.
- History of multiple myeloma or previous organ transplantation
- Elevated serum creatinine (\> 1.5mg/dl) OR calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula
- Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
- Evidence of severe symptomatic heart failure (NYHA Class III or IV);
- Known or suspected moderate or severe aortic stenosis
- History of prior percutaneous coronary intervention (PCI) in one or more vessel or history of coronary arterial bypass grafting (CABG)
- Suspected acute coronary syndrome
- Presence of any other history or condition that the investigator feels would be problematic
Where
- Baltimore, Maryland
Collaborators
Canon Medical Systems, USA
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations