CORE-COMPARE Pilot Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Aquilion Precision
  • Conventional Computed Tomography

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

Canon Medical Systems, USA

Collaborator