CORE-COMPARE Pilot Study

Official title

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

Overview

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]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

United States · 1 center

• Johns Hopkins School of Medicine — Baltimore

Identifiers

NCT: NCT06170541 · IRB00234130

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗