Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
302 participants
INTERVENTIONAL
2011-04-30
2012-08-31
Brief Summary
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To achieve best possible temporal resolution (minimize cardiac motion artifacts) and spatial resolution (provide diagnostic accuracy) relatively high radiation exposure is required, as a result of its inverse relationship with image noise and resolution. However radiation (X-ray) is associated with increased risk of cancer in exposed patients and it is therefore essential to continually devise strategies to reduce radiation exposure whilst maintaining image quality.
A state-of-art CT scanner (Discovery CT750 HD, General Electric (GE) Healthcare), has been installed at Derriford hospital for further research on CTCA. It uses novel method of scanning, High Definition Computed Tomographic Coronary Angiography(HD-CTCA), analogous to high definition television) and image reconstruction (Adaptive Statistical Iterative Reconstruction ASIR)as opposed to conventional CT scanners using Filtered Back Projection (FBP)reconstruction. HD-CTCA enables acquisition of sharper images and ASIR offsets the resultant increase in radiation exposure. This is likely to result in images of higher diagnostic quality with an equivalent or slightly lower radiation exposure compared to present technology. Although initial results are encouraging, this needs further assessment before being applied to routine clinical practice. To assess this we have designed a study to perform HD-CTCA on 300 consecutive patients undergoing diagnostic ICA at Derriford hospital, directly comparing the accuracy of HD-CTCA to ICA (presently considered the gold standard).
Hypotheses:
There is no significant difference in the sensitivity and specificity of HD-CTCA for the detection of coronary artery stenosis of 50% or greater compared to conventional ICA.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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Invasive coronary angiography (ICA)
Routine diagnostic ICA
Active Comparator: Invasive coronary angiography (ICA)
HD-CTCA with ASIR
HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)within 4 weeks of routine diagnostic ICA
HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)
Interventions
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HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)
Active Comparator: Invasive coronary angiography (ICA)
Eligibility Criteria
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Inclusion Criteria
* Suspected or known coronary artery disease
* Admitted for diagnostic ICA
Exclusion Criteria
* Age \<40 years
* New York Heart Association (NYHA) Functional Classification - class III or IV heart failure
* Emergency imaging required (not enough time to consider the trial)
* Allergy to iodinated contrast or previous contrast induced nephropathy
* Intolerance to betablockers
* Uncontrolled rhythm disturbances (not suitable for CTCA)
* Serum Creatinine \>200 micro mol/L within two weeks prior to procedure or chronic renal failure on dialysis
40 Years
ALL
No
Sponsors
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University Hospital Plymouth NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Carl Roobottom, BSc, MBChB(hon), MRCP. FRCR
Role: STUDY_CHAIR
University Hospital Plymouth NHS Trust
Srikanth Iyengar, MBBS, MS, FRCS, FRCR
Role: PRINCIPAL_INVESTIGATOR
University Hospital Plymouth NHS Trust
Locations
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Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom
Countries
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Other Identifiers
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11/H0206/5
Identifier Type: OTHER
Identifier Source: secondary_id
11/P/050
Identifier Type: -
Identifier Source: org_study_id