Coronary Artery DiseaseNCT01946737
High Definition CT Coronary Angiography Accuracy Trial
A study testing HD-CTCA with Adaptive statistical iterative reconstruction (ASIR) and Active Comparator: Invasive coronary angiography (ICA) in people with Coronary Artery Disease, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
CT technology is evolving at a rapid pace, with introduction of multidetector row CT scanners (MDCT) and electrocardiographic (ECG) gating resulting in increasing numbers of heart scans CTCA (CT Coronary Angiography). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- HD-CTCA with Adaptive statistical iterative reconstruction (ASIR) and Active Comparator: Invasive coronary angiography (ICA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Aug 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 40 years of age.
- Suspected or known coronary artery disease
- Admitted for diagnostic ICA
Who cannot join
- Consent cannot be obtained
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8BX
About this study
Official title: Diagnostic Performance of 64 Slice High Definition Computed Tomographic Coronary Angiography in Patients With High Risk of Significant Coronary Artery Disease.
CT technology is evolving at a rapid pace, with introduction of multidetector row CT scanners (MDCT) and electrocardiographic (ECG) gating resulting in increasing numbers of heart scans CTCA (CT Coronary Angiography). CTCA provides a noninvasive alternative to conventional invasive coronary angiography (ICA), which is considered the gold standard in the investigation of coronary disease. There has been a gradual increase in the utilization of CTCA for primary assessment of low and intermediate risk patients. However concerns regarding radiation exposure and diagnostic accuracy, especially in the highrisk group, have prevented its widespread dissemination.
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.
Read more
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.
- Conditions
- Coronary Artery Disease
- Being tested
- HD-CTCA with Adaptive statistical iterative reconstruction (ASIR), Active Comparator: Invasive coronary angiography (ICA)
- Keywords
- Coronary, Artery, Disease, Diagnostic, Performance, Angiography
- Medical subject headings
- Coronary Artery Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)Radiation
Active Comparator: Invasive coronary angiography (ICA)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Invasive coronary angiography (ICA) | Active comparator | Routine diagnostic ICA Receives: Radiation: Active Comparator: Invasive coronary angiography (ICA) |
| HD-CTCA with ASIR | Experimental | HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)within 4 weeks of routine diagnostic ICA Receives: Radiation: HD-CTCA with Adaptive statistical iterative reconstruction (ASIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of HD-CTCA for the detection of at least moderate stenosis (>50%) as defined on invasive coronary angiography in the high-risk target population.
We designed the New Generation Computed Tomographic Coronary Angiography (NG-CTCA) study to assess the diagnostic accuracy of high-definition CT with iterative reconstruction in an unselected population of patients suitable for CTCA with either a high pre-test probability of, or established coronary artery disease. Our hypothesis is that NGCT has a comparable diagnostic performance to invasive coronary angiography (ICA), using this as the reference standard
Measured: 4 weeks
Secondary outcomes (1)
The diagnostic accuracy of HD-CTCA for the detection of severe stenosis (70%) as defined by invasive coronary angiography.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl Roobottom, BSc, MBChB(hon), MRCP. FRCR, Study chair, University Hospital Plymouth NHS TrustSrikanth Iyengar, MBBS, MS, FRCS, FRCR, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946737
- Sponsor's protocol ID
- 11/P/050
- Other IDs
- 11/H0206/5
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of 64 Slice High Definition Computed Tomographic Coronary Angiography in Patients With High Risk of Significant Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT01946737
- Acronym / sponsor ID
- 11/P/050
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary, Artery, Disease, Diagnostic, Performance, Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Sep 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.
CT technology is evolving at a rapid pace, with introduction of multidetector row CT scanners (MDCT) and electrocardiographic (ECG) gating resulting in increasing numbers of heart scans CTCA (CT Coronary Angiography). CTCA provides a noninvasive alternative to conventional invasive coronary angiography (ICA), which is considered the gold standard in the investigation of coronary disease. There has been a gradual increase in the utilization of CTCA for primary assessment of low and intermediate risk patients. However concerns regarding radiation exposure and diagnostic accuracy, especially in the highrisk group, have prevented its widespread dissemination.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive coronary angiography (ICA) | Active comparator | Radiation: Active Comparator: Invasive coronary angiography (ICA)Routine diagnostic ICA |
| HD-CTCA with ASIR | Experimental | Radiation: HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)within 4 weeks of routine diagnostic ICA |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 40 years of age.
- Suspected or known coronary artery disease
- Admitted for diagnostic ICA
Key exclusion criteria (8 listed)
- Consent cannot be obtained
- 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
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 |
|---|---|---|
| HD-CTCA with Adaptive statistical iterative reconstruction (ASIR) | Radiation | HD-CTCA with ASIR |
| Active Comparator: Invasive coronary angiography (ICA) | Radiation | Invasive coronary angiography (ICA) |
Primary outcome
Diagnostic accuracy of HD-CTCA for the detection of at least moderate stenosis (>50%) as defined on invasive coronary angiography in the high-risk target population.
Time frame: 4 weeks
We designed the New Generation Computed Tomographic Coronary Angiography (NG-CTCA) study to assess the diagnostic accuracy of high-definition CT with iterative reconstruction in an unselected population of patients suitable for CTCA with either a high pre-test probability of, or established coronary artery disease. Our hypothesis is that NGCT has a comparable diagnostic performance to invasive coronary angiography (ICA), using this as the reference standard
1 secondary outcome
The diagnostic accuracy of HD-CTCA for the detection of severe stenosis (70%) as defined by invasive coronary angiography.
Time frame: 4 weeks
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 20 Sep 2013.
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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.
Carl Roobottom, BSc, MBChB(hon), MRCP. FRCR study chair
University Hospital Plymouth NHS Trust
Srikanth Iyengar, MBBS, MS, FRCS, FRCR principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD-CTCA with Adaptive statistical iterative reconstruction (ASIR) and Active Comparator: Invasive coronary angiography (ICA) in people with 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 3 inclusion and 8 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 20 Sep 2013. 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?
Diagnostic accuracy of HD-CTCA for the detection of at least moderate stenosis (>50%) as defined on invasive coronary angiography in the high-risk target population. (time frame: 4 weeks). 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 20 Sep 2013.