High Risk of Significant Coronary Artery Disease Clinical Trial
Official title:
Pilot Study to Assess the Feasibility and Diagnostic Performance of Computed Tomographic Coronary Angiography Using Cardiac Gemstone Spectral Imaging (Cardiac GSI) in Patients With High-risk of Significant Coronary Artery Disease and Myocardial Scar
The recently introduced Computed tomography (CT) scanner, Discovery CT750 HD (GE Healthcare,
Milwaukee), incorporates a battery of innovations aimed at improving diagnostic image
quality, evaluating perfusion and assessing for scar, in an effort to address the current
shortcomings of Computed tomographic coronary angiography (CTCA) in patients with
significant coronary artery disease. The new scanner will use a novel method of scanning
(Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive
Statistical Iterative Reconstruction- ASIR) as opposed to standard definition 64-slice CT
Multi-detector row computed tomography(MDCT)and Filtered Back Projection (FBP) used by the
conventional CT scanners. The Cardiac GSI protocol enables the scanner to acquire images at
two different x-ray energies almost simultaneously, which can be post-processed to
selectively reduce beam hardening artefacts and delete materials with specific attenuating
properties from the images, such as coronary calcium. ASIR offsets the potential increase in
radiation dose required for Cardiac GSI scanning. This will potentially result in images of
higher diagnostic quality with an equivalent or perhaps lower dose of radiation compared to
present technology.
Furthermore, it is hypothesised that dual-energy acquisition may improve the accuracy of the
assessment of perfusion.
Although initial in-vitro results are encouraging, this technology has not been rigorously
assessed with regards to its feasibility and diagnostic quality, limiting its applicability
in routine clinical practice. This assessment will require a trial comparing the accuracy of
Cardiac GSI CTCA with that of Invasive coronary angiography (ICA) for anatomical assessment
of stenosis, Myocardial Perfusion Imaging with Single Photon Emission Computed Tomography
(MPI-SPECT) for assessment of perfusion and Cardiac Magnetic Resonance (CMR) for assessment
of myocardial scar. We have designed a pilot study in this regard which will help us assess
the feasibility of the scan protocol and provide data to power a larger study to assess the
diagnostic remit of Cardiac GSI scanning in the assessment of patients with high-risk of
significant coronary artery disease and myocardial scar.
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic