CORE-COMPARE Pilot Study

Conditions

• Coronary Heart Disease (CHD)

Eligibility Criteria

Sex

ALL

Age

21 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Apr 5, 2021

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

140 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision)
  Participants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality.
• Active Comparator: CR-CT (Conventional Resolution Computed Tomography)
  Participants in this arm receive CT scans using the Conventional Resolution CT imaging modality.

Primary Outcome 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. [ Time Frame: Up to 24 Months ]

Central Contacts

• Joao Lima, Professor
  4106141284
  [email protected]

Locations (1)

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