Clinical trial NCT01816750: Cardiac GSI Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk of Significant Coronary Artery Disease
Keywords: CT coronary angiography
Coronary disease
Gemstone Spectral Imaging
Diagnostic value
Adaptive statistical iterative reconstruction
iterative reconstruction
Feasibility of coronary and myocardial assessment
novel Cardiac CT GSI protocol
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Accuracy arm

* Patients \>50 years of age
* Suspected or known coronary artery disease referred for ICA

Stress perfusion arm

* Patients \>50 years of age
* Suspected or established coronary artery disease referred for MPI-SPECT for assessment of inducible ischaemia

Delayed enhancement arm

* Patients \>50 years of age
* Referred for CMR for assessment of myocardial viability/scar

Exclusion Criteria:

Accuracy arm

* Consent cannot be obtained
* Patient BMI \> 30 kg /m2
* NYHA class III or IV heart failure
* Chronic total occlusion of target epicardial coronary artery
* Urgent revascularisation required
* Allergy to iodinated contrast or previous contrast induced nephropathy
* Intolerance or contraindication to beta-blockers
* Uncontrolled heart rhythm disturbances
* 2nd or 3rd degree atrioventricular block
* Estimated glomerular filtration rate \<30ml/min within two weeks prior to procedure or chronic renal failure on dialysis
* Pregnancy

Stress perfusion arm

* As above, plus:
* Asthma (any) or intolerance to adenosine

Delayed enhancement arm

- As for Accuracy arm

Primary outcomes:
measure: Feasibility - Assessment of rates of recruitment, acceptability of the procedure to patients, ease of CT acquisition
timeFrame: 4 months
Secondary outcomes:
measure: radiation burden of the Cardiac GSI techniques
timeFrame: 4 months
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
Study officials:
affiliation: Plymouth Hospitals NHS Trust (UK)
name: Ben Clayton, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Plymouth Hospitals NHS Trust (UK)
name: Gareth Morgan-Hughes, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Plymouth Hospitals NHS Trust (UK)
name: Franchesca Wotton, MBBS
role: STUDY_DIRECTOR
References: