Clinical trial NCT06170541: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Heart Disease (CHD)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Canon Medical Systems, USA
First posted: 2023-12-14
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: blinded, prospective single-center study.
Primary purpose: OTHER

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 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: 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

Primary outcomes:
measure: 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.
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Segment-Based Analysis for Obstructive Stenosis:
timeFrame: Up to 24 Months
measure: Diagnostic Confidence Assessment:
timeFrame: Up to 24 Months
measure: Interobserver Variability Analysis:
timeFrame: Up to 24 Months
measure: Assessment of vascular and plaque metrics:
timeFrame: Up to 24 Months
measure: Pericoronary Adipose Tissue Analysis:
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: MD
name: Joao Lima, Professor
role: PRINCIPAL_INVESTIGATOR
References: