CORE-COMPARE Pilot Study

NCT06170541 | Recruiting FDA Device

• 1 other identifier: IRB00234130
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 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)

Outcome Measures

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.

  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.

  Up to 24 Months

Secondary Outcomes (5)

• Segment-Based Analysis for Obstructive Stenosis:

  Up to 24 Months

• Diagnostic Confidence Assessment:

  Up to 24 Months

• Interobserver Variability Analysis:

  Up to 24 Months

• Assessment of vascular and plaque metrics:

  Up to 24 Months

• Pericoronary Adipose Tissue Analysis:

  Up to 24 Months

Study Arms (2)

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.

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.

Device: Conventional Computed Tomography

Interventions

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.

UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision)

Conventional Computed Tomography DEVICE

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

CR-CT (Conventional Resolution Computed Tomography)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canon Medical Systems, USA: collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Joao Lima, Professor

  MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao Lima, Professor

CONTACT

4106141284; jlima@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: blinded, prospective single-center study.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: December 14, 2023
• Study Start: April 5, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 12 months after article publication. Data will be made accessible up to 24 months with extensions considered as needed.
• Access Criteria: Access provided upon request.

Locations

US (1)