Coronary Heart Disease (CHD)NCT06170541
CORE-COMPARE Pilot Study
A study testing Aquilion Precision and Conventional Computed Tomography in people with Coronary Heart Disease (CHD), run by Johns Hopkins University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- Aquilion Precision and Conventional Computed Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Michelle lHughes-Lukoski, mhughe17@jh.edu
About this study
Official title: Ultra-High Resolution Computed Tomography (CT) vs. Conventional CT for Detecting Obstructive Coronary Artery Disease (CAD) The CORE-COMPARE Pilot Study
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.
- Conditions
- Coronary Heart Disease (CHD)
- Being tested
- Aquilion Precision, Conventional Computed Tomography
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquilion PrecisionDevice
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.
Conventional Computed TomographyDevice
Conventional reconstruction Computed Tomography (CT) represents a pivotal approach in medical imaging.
| Study group | Role | What they receive |
|---|---|---|
| UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision) | Experimental | Participants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality. Receives: Device: Aquilion Precision |
| CR-CT (Conventional Resolution Computed Tomography) | Active comparator | Participants in this arm receive CT scans using the Conventional Resolution CT imaging modality. Receives: Device: Conventional Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Up to 24 Months
Secondary outcomes (5)
Segment-Based Analysis for Obstructive Stenosis:
Stenosis greater than 70% and 50-69% will be identified and flagged in both imaging modalities (UHRCT and CRCT). The agreement in identifying these specific levels of stenosis will be compared.
Measured: Up to 24 Months
Diagnostic Confidence Assessment:
Confidence level will be classified by the 2 observers for both imaging modalities using the following scale: 1. Very Unsure, 2. Unsure, 3. Moderately Confident, 4. Confident, 5. Highly Confident.
Measured: Up to 24 Months
Interobserver Variability Analysis:
The agreement in the stenosis classification at patient and vessel level will be assessed using Cohen's kappa statistic.
Measured: Up to 24 Months
Assessment of vascular and plaque metrics:
A comparison will be performed between both imaging modalities for the following parameters: vessel volume, lumen volume, wall/lumen ratio, total plaque volume, percentage of calcified component, percentage of non-calcified component.
Measured: Up to 24 Months
Pericoronary Adipose Tissue Analysis:
The perivascular fat attenuation index (FAI) will be calculated for all the three major vessels, right coronary artery (RCA), left circumflex artery (LCX) and left anterior descending (LAD) in both datasets and the results will be compared.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start5 Apr 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- blinded, prospective single-center study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Joao Lima, Professor, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170541
- Sponsor's protocol ID
- IRB00234130
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-High Resolution Computed Tomography (CT) vs. Conventional CT for Detecting Obstructive Coronary Artery Disease (CAD) The CORE-COMPARE Pilot Study
- ClinicalTrials.gov ID
- NCT06170541
- Acronym / sponsor ID
- IRB00234130
- Conditions
- Coronary Heart Disease (CHD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- blinded, prospective single-center study.
| Arm | Type | Receives |
|---|---|---|
| UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision) | Experimental | Device: Aquilion PrecisionParticipants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality. |
| CR-CT (Conventional Resolution Computed Tomography) | Active comparator | Device: Conventional Computed TomographyParticipants in this arm receive CT scans using the Conventional Resolution CT imaging modality. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquilion PrecisionUltra-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 | UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision) |
| Conventional Computed TomographyConventional reconstruction Computed Tomography (CT) represents a pivotal approach in medical imaging. | Device | CR-CT (Conventional Resolution Computed Tomography) |
Primary outcome
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.
5 secondary outcomes
Segment-Based Analysis for Obstructive Stenosis:
Time frame: Up to 24 Months
Diagnostic Confidence Assessment:
Time frame: Up to 24 Months
Interobserver Variability Analysis:
Time frame: Up to 24 Months
Assessment of vascular and plaque metrics:
Time frame: Up to 24 Months
Pericoronary Adipose Tissue Analysis:
Time frame: Up to 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joao Lima, Professor principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquilion Precision and Conventional Computed Tomography in people with Coronary Heart Disease (CHD), run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joao Lima, Professor (4106141284, jlima@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.