Status:
RECRUITING
CORE-COMPARE Pilot Study
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Canon Medical Systems, USA
Conditions:
Coronary Heart Disease (CHD)
Eligibility:
All Genders
21-85 years
Phase:
NA
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 5 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06170541
Start Date
April 5 2021
End Date
April 5 2027
Last Update
December 9 2025
Active Locations (1)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205