CORE-COMPARE Pilot Study

Johns Hopkins University

Status: Enrolling

Conditions: Coronary Heart Disease (CHD)

Treatments: Device: Aquilion Precision; Device: Conventional Computed Tomography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06170541

IRB00234130

Details and patient eligibility

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. 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

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

Experimental group

Description:

Participants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality.

Treatment:

Device: Aquilion Precision

CR-CT (Conventional Resolution Computed Tomography)

Active Comparator group

Description:

Participants in this arm receive CT scans using the Conventional Resolution CT imaging modality.

Treatment:

Device: Conventional Computed Tomography