Cardiac GSI Feasibility Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Plymouth Hospitals NHS Trust
Sponsor:
Information provided by (Responsible Party):
Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01816750
First received: February 28, 2013
Last updated: May 30, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention
High Risk of Significant Coronary Artery Disease
Device: Cardiac GSI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Plymouth Hospitals NHS Trust:

Primary Outcome Measures:
  • Feasibility - Assessment of rates of recruitment, acceptability of the procedure to patients, ease of CT acquisition [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    Assessment of rates of recruitment, acceptability of the procedure to patients, ease of CT acquisition. This pilot study will add to this assessment with specific information about the diagnostic performance of the novel scanning technique:

    • Are images of sufficient quality to be diagnostic?
    • Is diagnosis likely to be non-inferior to current comparable techniques, sufficient to justify a formal study?


Secondary Outcome Measures:
  • radiation burden of the Cardiac GSI techniques [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    The Discovery CT750 HD scanner uses a new image reconstruction technique called Adaptive Statistical Iterative Reconstruction (ASIR). ASIR uses more complex mathematical modelling for image reconstruction, thus reducing the need for statistical assumptions and reducing image noise and artefact. It also requires the less raw data and thus significantly less radiation dose. Studies suggest that using ASIR can achieve up to 40% dose reduction compared to Filtered Back Projection (FBP).

    However, the effect of ASIR and radiation dose reducing algorithms on image quality and accuracy has not been assessed and the difference in image quality and artefact suppression using the new technology remains to be established before its widespread dissemination into clinical practice.



Estimated Enrollment: 70
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anatomical accuracy Cardiac GSI vs ICA
The identification and quantification of coronary artery stenoses using Cardiac in comparison to ICA.
Device: Cardiac GSI
A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.
Other Name: Cardiac Gemstone Spectral Imaging
Experimental: Stress perfusion Cardiac GSI vs MPI-SPECT
Assessment of the functional impact of coronary stenoses using Cardiac GSI in comparison to MPI-SPECT
Device: Cardiac GSI
A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.
Other Name: Cardiac Gemstone Spectral Imaging
Experimental: Delayed enhancement Cardiac GSI vs CMR
Assessment of abnormal myocardial tissue characteristics representing ischaemic or scarred tissue using Cardiac GSI in comparison to CMR.
Device: Cardiac GSI
A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.
Other Name: Cardiac Gemstone Spectral Imaging

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816750

Contacts
Contact: Ben Clayton 0845 155 8155 benjamin.clayton@nhs.net
Contact: Gareth Morgan-Hughes gareth.morgan-hughes@nhs.net

Locations
United Kingdom
Plymouth Hospitals NHS Trust Recruiting
Plymouth, Devon, United Kingdom, PL6 8DH
Contact: Chris Rollinson, PhD    01752 431045    crollinson@nhs.net   
Principal Investigator: Gareth Morgan-Hughes         
Sponsors and Collaborators
Plymouth Hospitals NHS Trust
Investigators
Study Director: Ben Clayton Plymouth Hospitals NHS Trust (UK)
Principal Investigator: Gareth Morgan-Hughes Plymouth Hospitals NHS Trust (UK)
  More Information

No publications provided

Responsible Party: Plymouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01816750     History of Changes
Other Study ID Numbers: 13/P/031, 13/SW/0065
Study First Received: February 28, 2013
Last Updated: May 30, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Plymouth Hospitals NHS Trust:
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014