StenosesNCT02179957
Visual Estimation of Coronary Fractional Flow Reserve From High-definition Computed Tomographic Coronary Angiography
An observational study of Stenoses and Ischaemia, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
The identification of abnormal narrowing of a blood vessel from non-invasive coronary angiography remains an exciting goal. While Computed Tomography (CT) has established a clear role in patients it retains some limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Jun 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary stenoses which have been analysed with both CT and FFR
Who may be able to join
- Patients with coronary stenoses which have been analysed with both CT and FFR
Who cannot join
- Under 18 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH
About this study
The identification of abnormal narrowing of a blood vessel from non-invasive coronary angiography remains an exciting goal. While Computed Tomography (CT) has established a clear role in patients it retains some limitations. Primarily, alterations in blood flow leading to a restriction in blood supply to tissues cannot be accurately predicted from the anatomical assessment of an abnormal narrowing in a blood vessel - a limitation of both invasive, and computed tomographic, angiography. This is important, as there is now a raft of evidence demonstrating that revascularisation should only be considered in the presence of a restriction in blood supply to tissues.
The gold standard method of identifying a restriction in blood supply to tissues is measurement of the fractional flow reserve (FFR), a dimensionless value generated as a ratio between the circulatory pressure before and after a narrowing of a blood vessel.
Read more
At present, patients with indeterminately significant abnormal narrowing in a blood vessel identified using CT must go on to have a further test for a restriction in blood supply to tissues, prior to any decision about revascularisation being made.
As part of our governance commitment to maintaining our reporting standards, we undertake ongoing audit of our cardiac CT practice. The investigators recently identified a group of patients who have undergone FFR measurement as part of routine clinical care, and compared these to our clinical reports, to ensure that appropriate recommendations were being made. It appeared that the ability to predict important abnormal narrowing in a blood vessel was reasonable (~70%) and hence we propose the formulation of a research question to explore this further.
The primary objective of this study is to determine the accuracy of a visual assessment of the likely significance on blood flow of a narrowing of a blood vessel identified on cardiac CT, in comparison to invasive, fractional flow reserve.
The secondary objective is to evaluate features of an abnormal narrowing in a blood vessel that is likely to have a significant impact on blood flow.
The investigators' working hypothesis is that cardiac CT FFR is a useful predictor of abnormal narrowing in a blood vessel.
Read the detailed description
This is a retrospective study of diagnostic accuracy. We do not intend to undertake any intervention or require patient involvement at any stage of this research.
The study would utilise anonymised patient data, identified as part of the previous audit. FFR values are already known for each patient. The image dataset would be retrieved and matched to an FFR. At this stage all data, including the images, would be anonymised. The images would be reviewed independently by two expert readers who would record their impression of the likely haemodynamic significance of a particular stenosis. Two weeks later, to minimise bias, the readers would re-review the images to identify features of the stenoses known, or likely, to cause haemodynamic significance, including stenosis length, territory of the vessel, calcification.
The results would be directly compared to the FFR readings and the features would be subjected to multivariate analysis to identify any salient anatomical feature which may predict haemodynamic significance.
- Keywords
- Stenoses, Ischaemia, haemodynamics, fractional flow reserve (FFR), computed tomography (CT), cardiac
- Medical subject headings
- Constriction, Pathologic, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CT and FFR | Coronary stenoses which have been analysed with both CT and FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of a visual assessment of the likely haemodynamic significance of a stenosis identified on cardiac CT, in comparison to invasive, fractional flow reserve.
The outcome measures will be the sensitivity, specificity, positive \& negative predictive values, and overall accuracy of the visual assessment .
Measured: 2 weeks
Secondary outcomes (1)
Odds ratios for features felt likely to contribute to the diagnosis (stenosis severity, stenosis length, proportion of downstream myocardium supplied, use of high-definition scanning)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StenosesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Clayton, MBBS, Principal investigator, Plymouth Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179957
- Sponsor's protocol ID
- 14/P/066
- Other IDs
- 14/WS/0121
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Estimation of Coronary Fractional Flow Reserve From High-definition Computed Tomographic Coronary Angiography
- ClinicalTrials.gov ID
- NCT02179957
- Acronym / sponsor ID
- 14/P/066
- Keywords
- Stenoses, Ischaemia, haemodynamics, fractional flow reserve (FFR), computed tomography (CT), cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Jul 2014 (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 identification of abnormal narrowing of a blood vessel from non-invasive coronary angiography remains an exciting goal. While Computed Tomography (CT) has established a clear role in patients it retains some limitations. Primarily, alterations in blood flow leading to a restriction in blood supply to tissues cannot be accurately predicted from the anatomical assessment of an abnormal narrowing in a blood vessel - a limitation of both invasive, and computed tomographic, angiography. This is important, as there is now a raft of evidence demonstrating that revascularisation should only be considered in the presence of a restriction in blood supply to tissues.
The gold standard method of identifying a restriction in blood supply to tissues is measurement of the fractional flow reserve (FFR), a dimensionless value generated as a ratio between the circulatory pressure before and after a narrowing of a blood vessel.
At present, patients with indeterminately significant abnormal narrowing in a blood vessel identified using CT must go on to have a further test for a restriction in blood supply to tissues, prior to any decision about revascularisation being made.
As part of our governance commitment to maintaining our reporting standards, we undertake ongoing audit of our cardiac CT practice. The investigators recently identified a group of patients who have undergone FFR measurement as part of routine clinical care, and compared these to our clinical reports, to ensure that appropriate recommendations were being made. It appeared that the ability to predict important abnormal narrowing in a blood vessel was reasonable (~70%) and hence we propose the formulation of a research question to explore this further.
The primary objective of this study is to determine the accuracy of a visual assessment of the likely significance on blood flow of a narrowing of a blood vessel identified on cardiac CT, in comparison to invasive, fractional flow reserve.
The secondary objective is to evaluate features of an abnormal narrowing in a blood vessel that is likely to have a significant impact on blood flow.
The investigators' working hypothesis is that cardiac CT FFR is a useful predictor of abnormal narrowing in a blood vessel.
Detailed description
This is a retrospective study of diagnostic accuracy. We do not intend to undertake any intervention or require patient involvement at any stage of this research.
The study would utilise anonymised patient data, identified as part of the previous audit. FFR values are already known for each patient. The image dataset would be retrieved and matched to an FFR. At this stage all data, including the images, would be anonymised. The images would be reviewed independently by two expert readers who would record their impression of the likely haemodynamic significance of a particular stenosis. Two weeks later, to minimise bias, the readers would re-review the images to identify features of the stenoses known, or likely, to cause haemodynamic significance, including stenosis length, territory of the vessel, calcification.
The results would be directly compared to the FFR readings and the features would be subjected to multivariate analysis to identify any salient anatomical feature which may predict haemodynamic significance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT and FFR | – | –Coronary stenoses which have been analysed with both CT and FFR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary stenoses which have been analysed with both CT and FFR
Key inclusion criteria (1 listed)
- Patients with coronary stenoses which have been analysed with both CT and FFR
Key exclusion criteria (1 listed)
- Under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of a visual assessment of the likely haemodynamic significance of a stenosis identified on cardiac CT, in comparison to invasive, fractional flow reserve.
Time frame: 2 weeks
The outcome measures will be the sensitivity, specificity, positive \& negative predictive values, and overall accuracy of the visual assessment .
1 secondary outcome
Odds ratios for features felt likely to contribute to the diagnosis (stenosis severity, stenosis length, proportion of downstream myocardium supplied, use of high-definition scanning)
Time frame: 2 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 2 Jul 2014.
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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.
Benjamin Clayton, MBBS principal investigator
Plymouth Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenoses and Ischaemia, 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 1 inclusion and 1 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 2 Jul 2014. 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?
Accuracy of a visual assessment of the likely haemodynamic significance of a stenosis identified on cardiac CT, in comparison to invasive, fractional flow reserve. (time frame: 2 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 2 Jul 2014.