Health TrialsbyHealthPanel

CORE-COMPARE Pilot Study

ConditionCoronary Heart Disease (CHD)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Aquilion Precision

    Device

    Ultra-High Resolution CT (UHR CT) capable of resolving anatomy as small as 150 microns, providing CT image quality with resolution typically seen only in cath labs. The UHR detector is newly designed to provide more than twice the resolution when compared with today's CT technology, with an all-new detector as well as tube, gantry and reconstruction technologies.

  • Conventional Computed Tomography

    Device

    Conventional reconstruction Computed Tomography (CT) represents a pivotal approach in medical imaging.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision)Experimental treatment 1 intervention
Group B: CR-CT (Conventional Resolution Computed Tomography)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

The ultra-high-resolution CT images (UHRCT) and the reconstructed conventional CT resolution images (CRCT) will be independently reviewed by two observers (with a 60-day washout period between both images). The stenoses will be classified according to the Society of Cardiovascular Computed Tomography (SCCT) classification system (\<25%, 25-49%, 50-69%, 70-99%, and occluded). Patients with stenosis greater than 70% will be flagged. The primary outcome will be assessed for patients that underwent a clinically indicated invasive angiography (ICA). To compare agreement between UHRCT and CRCT studies while using ICA as the gold-standard, a concordance meta-analysis will be employed. This involves evaluating the agreement measures from each study, standardizing the results, and then comparing the concordance results of the two studies with the third study, considered the gold standard.

Time frame
Up to 24 Months

Secondary outcomes

1

Segment-Based Analysis for Obstructive Stenosis:

Stenosis greater than 70% and 50-69% will be identified and flagged in both imaging modalities (UHRCT and CRCT). The agreement in identifying these specific levels of stenosis will be compared.

Time frame
Up to 24 Months
2

Diagnostic Confidence Assessment:

Confidence level will be classified by the 2 observers for both imaging modalities using the following scale: 1. Very Unsure, 2. Unsure, 3. Moderately Confident, 4. Confident, 5. Highly Confident.

Time frame
Up to 24 Months
3

Interobserver Variability Analysis:

The agreement in the stenosis classification at patient and vessel level will be assessed using Cohen's kappa statistic.

Time frame
Up to 24 Months
4

Assessment of vascular and plaque metrics:

A comparison will be performed between both imaging modalities for the following parameters: vessel volume, lumen volume, wall/lumen ratio, total plaque volume, percentage of calcified component, percentage of non-calcified component.

Time frame
Up to 24 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Canon Medical Systems, USA

Collaborator

Source ClinicalTrials.gov
Apply now