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NCT Number: NCT06170541

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.

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Key information

Conditions

Coronary Heart Disease (CHD) Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Michelle lHughes-Lukoski

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquilion Precision

Device

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 Tomography

Device

Conventional reconstruction Computed Tomography (CT) represents a pivotal approach in medical imaging.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Segment-Based Analysis for Obstructive Stenosis:

    Time frame: Up to 24 Months

    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.

  2. Diagnostic Confidence Assessment:

    Time frame: Up to 24 Months

    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.

  3. Interobserver Variability Analysis:

    Time frame: Up to 24 Months

    The agreement in the stenosis classification at patient and vessel level will be assessed using Cohen's kappa statistic.

  4. Assessment of vascular and plaque metrics:

    Time frame: Up to 24 Months

    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.

  5. Pericoronary Adipose Tissue Analysis:

    Time frame: Up to 24 Months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joao Lima, Professor

CONTACT

[email protected]

4106141284

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Canon Medical Systems, USA

Registry information

Official study title

Ultra-High Resolution Computed Tomography (CT) vs. Conventional CT for Detecting Obstructive Coronary Artery Disease (CAD) The CORE-COMPARE Pilot Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 14, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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