Completed

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

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What is being tested

Cardiac GSI

+ Cardiac GSI

+ Cardiac GSI

Device
Who is being recruted

Cardiovascular Diseases+2

+ Heart Diseases

+ Vascular Diseases

Over 50 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity Hospital Plymouth NHS Trust
Last updated: October 24, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01816750
Principal SponsorUniversity Hospital Plymouth NHS Trust
Last updated: October 24, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Disease

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Plymouth Hospitals NHS Trust

Plymouth, United KingdomOpen Plymouth Hospitals NHS Trust in Google Maps
CompletedOne Study Center