High Risk of Significant Coronary Artery DiseaseNCT01816750
Cardiac GSI Feasibility Study
A study testing Cardiac GSI in people with High Risk of Significant Coronary Artery Disease, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- High Risk of Significant Coronary Artery Disease
- What is being tested?
- Cardiac GSI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Delayed enhancement arm
- Patients >50 years of age
- Referred for CMR for assessment of myocardial viability/scar
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH
About this 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
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.
- Being tested
- Cardiac GSI
- 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
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac GSIDevice
Also called Cardiac Gemstone Spectral Imaging
A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.
| Study group | Role | What they receive |
|---|---|---|
| Anatomical accuracy Cardiac GSI vs ICA | Experimental | The identification and quantification of coronary artery stenoses using Cardiac in comparison to ICA. Receives: Device: Cardiac GSI |
| Stress perfusion Cardiac GSI vs MPI-SPECT | Experimental | Assessment of the functional impact of coronary stenoses using Cardiac GSI in comparison to MPI-SPECT Receives: Device: Cardiac GSI |
| Delayed enhancement Cardiac GSI vs CMR | Experimental | Assessment of abnormal myocardial tissue characteristics representing ischaemic or scarred tissue using Cardiac GSI in comparison to CMR. Receives: Device: Cardiac GSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Assessment of rates of recruitment, acceptability of the procedure to patients, ease of CT acquisition
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?
Measured: 4 months
Secondary outcomes (1)
radiation burden of the Cardiac GSI techniques
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk of Significant Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben Clayton, MBBS, Principal investigator, Plymouth Hospitals NHS Trust (UK)Gareth Morgan-Hughes, MBBS, Principal investigator, Plymouth Hospitals NHS Trust (UK)Franchesca Wotton, MBBS, Study director, Plymouth Hospitals NHS Trust (UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816750
- Sponsor's protocol ID
- 13/P/031
- Other IDs
- 13/SW/0065
- Status last verified
- Oct 2016
- First submitted
- 28 Feb 2013
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01816750
- Acronym / sponsor ID
- 13/P/031
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anatomical accuracy Cardiac GSI vs ICA | Experimental | Device: Cardiac GSIThe identification and quantification of coronary artery stenoses using Cardiac in comparison to ICA. |
| Stress perfusion Cardiac GSI vs MPI-SPECT | Experimental | Device: Cardiac GSIAssessment of the functional impact of coronary stenoses using Cardiac GSI in comparison to MPI-SPECT |
| Delayed enhancement Cardiac GSI vs CMR | Experimental | Device: Cardiac GSIAssessment of abnormal myocardial tissue characteristics representing ischaemic or scarred tissue using Cardiac GSI in comparison to CMR. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Accuracy arm
- Patients >50 years of age
- Suspected or known coronary artery disease referred for ICA
- Stress perfusion arm
- Patients >50 years of age
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac GSIAlso: Cardiac Gemstone Spectral ImagingA novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR. | Device | Anatomical accuracy Cardiac GSI vs ICA, Delayed enhancement Cardiac GSI vs CMR, Stress perfusion Cardiac GSI vs MPI-SPECT |
Primary outcome
Feasibility - Assessment of rates of recruitment, acceptability of the procedure to patients, ease of CT acquisition
Time frame: 4 months
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?
1 secondary outcome
radiation burden of the Cardiac GSI techniques
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Clayton, MBBS principal investigator
Plymouth Hospitals NHS Trust (UK)
Gareth Morgan-Hughes, MBBS principal investigator
Plymouth Hospitals NHS Trust (UK)
Franchesca Wotton, MBBS study director
Plymouth Hospitals NHS Trust (UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac GSI in people with High Risk of Significant Coronary Artery Disease, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Assessment of rates of recruitment, acceptability of the procedure to patients, ease of CT acquisition (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.