Cardiac GSI Feasibility Study

NCT ID: NCT01816750

Last Updated: 2016-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-06-30

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.

Conditions

High Risk of Significant Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Anatomical accuracy Cardiac GSI vs ICA

The identification and quantification of coronary artery stenoses using Cardiac in comparison to ICA.

Group Type: EXPERIMENTAL

Cardiac GSI

Intervention Type: DEVICE

A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.

Stress perfusion Cardiac GSI vs MPI-SPECT

Assessment of the functional impact of coronary stenoses using Cardiac GSI in comparison to MPI-SPECT

Group Type: EXPERIMENTAL

Cardiac GSI

Intervention Type: DEVICE

A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.

Delayed enhancement Cardiac GSI vs CMR

Assessment of abnormal myocardial tissue characteristics representing ischaemic or scarred tissue using Cardiac GSI in comparison to CMR.

Group Type: EXPERIMENTAL

Cardiac GSI

Intervention Type: DEVICE

A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.

Interventions

Cardiac GSI

A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.

Intervention Type: DEVICE

Other Intervention Names

Cardiac Gemstone Spectral Imaging

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Clayton, MBBS

Role: PRINCIPAL_INVESTIGATOR

Plymouth Hospitals NHS Trust (UK)

Gareth Morgan-Hughes, MBBS

Role: PRINCIPAL_INVESTIGATOR

Plymouth Hospitals NHS Trust (UK)

Franchesca Wotton, MBBS

Role: STUDY_DIRECTOR

Plymouth Hospitals NHS Trust (UK)

Locations

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

13/SW/0065

Identifier Type: OTHER

Identifier Source: secondary_id

13/P/031

Identifier Type: -

Identifier Source: org_study_id