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.
Conditions:
🦠 Coronary Heart Disease (CHD)
🗓️ Study Start (Actual) 5 April 2021
🗓️ Primary Completion (Estimated) 5 April 2026
✅ Study Completion (Estimated) 5 April 2027
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 March 2021
  • First Submitted that Met QC Criteria 5 December 2023
  • First Posted 14 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 December 2023
  • Last Update Posted 14 December 2023
  • Last Verified December 2023