Acute Aortic SyndromeNCT02273245
Is a Pre-contrast Scan Necesary to Diagnose Acute Aortic Syndrome?
An observational study of Acute Aortic Syndrome, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest pain. There are several possible underlying causes, which cannot be distinguished from one another at the bedside. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Aortic Syndrome
- What is being tested?
- Thoracic aortogram CT
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Oct 2015
- 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: A retrospective cohort assessment of thoracic aortogram CTs of male and female adult (age>18) patients presenting with symptoms of AAS.
Who may be able to join
- male and female adult (age>18) patients presenting with symptoms of AAS who had thoracic aortogram CTs.
Who cannot join
- age<18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8BX
About this study
Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest pain. There are several possible underlying causes, which cannot be distinguished from one another at the bedside.
Current practice is to image this with two CT scans of the chest, one before injection of a contrast dye into the blood stream and then one after.
With the advancement of CT scanner technology, improvements in software interpretation and screen resolution, the investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans
Read the detailed description
AAS include: a tear in the wall of the main artery from the heart, bleeding directly into this wall, an ulcer in the wall, and excess dilatation and rupture of the main artery wall. These are also treated differently according to where they are in the length of the aorta. It is therefore important to identify precisely the subtype of AAS and its location to allow the clinician to manage the patient appropriately.
Current practice is to image this with two CT scans of the chest, one before injection of a contrast dye into the blood stream and then one after. The one before the contrast is used to determine if there is bleeding within the wall, which would show up as white on this scan. It is currently accepted that the contrast in the artery itself would hide the presence of bleeding within the wall. The other causes are seen primarily on the contrast scan only. Every patient proceeds from the pre-contrast scan to the contrast scan, unless there is a contraindication to the intravenous dye.
The investigators own database search has shown that radiologists protocol the scans according to their own preference and experience (i.e. some do both scans, others the contrast scan only). There is conflicting advice from international professional bodies as to whether to perform the non-contrast scan every time.
Some studies have shown that although the pre-contrast scan is sensitive to picking up bleeding within the wall, it adds nothing more over an increased radiation dose to the patient.
The investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans to look for all 4 of these entities that make up AAS. The investigators also propose that not requiring the pre-contrast scan would have significant savings in patient radiation dose, scanner time, network resources and radiologist time.
- Conditions
- Acute Aortic Syndrome
- Being tested
- Thoracic aortogram CT
- Medical subject headings
- Acute Aortic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic aortogram CTRadiation
With and without contrast dye
| Study group | Role | What they receive |
|---|---|---|
| thoracic aortgram CTs | A retrospective cohort assessment of thoracic aortogram CTs of male and female adult (age>18) patients presenting with symptoms of AAS. Receives: Radiation: Thoracic aortogram CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded review
2 experienced reporters are asked to blind view, in random order, either a contrast scan only, or a pair of pre- and post-contrast scans and report on an Excel spreadsheet.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Aortic SyndromeStudies 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl Roobottom, MBChB FRCP, Study director, Plymouth Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273245
- Sponsor's protocol ID
- 14/P/155
- Status last verified
- Nov 2015
- First submitted
- 21 Oct 2014
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Pre-contrast Scan Necesary to Diagnose Acute Aortic Syndrome?
- ClinicalTrials.gov ID
- NCT02273245
- Acronym / sponsor ID
- 14/P/155
- Conditions
- Acute Aortic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Oct 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.
Acute Aortic Syndrome (AAS) is a potentially life-threatening cause of sudden, severe chest pain. There are several possible underlying causes, which cannot be distinguished from one another at the bedside.
Current practice is to image this with two CT scans of the chest, one before injection of a contrast dye into the blood stream and then one after.
With the advancement of CT scanner technology, improvements in software interpretation and screen resolution, the investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans
Detailed description
AAS include: a tear in the wall of the main artery from the heart, bleeding directly into this wall, an ulcer in the wall, and excess dilatation and rupture of the main artery wall. These are also treated differently according to where they are in the length of the aorta. It is therefore important to identify precisely the subtype of AAS and its location to allow the clinician to manage the patient appropriately.
Current practice is to image this with two CT scans of the chest, one before injection of a contrast dye into the blood stream and then one after. The one before the contrast is used to determine if there is bleeding within the wall, which would show up as white on this scan. It is currently accepted that the contrast in the artery itself would hide the presence of bleeding within the wall. The other causes are seen primarily on the contrast scan only. Every patient proceeds from the pre-contrast scan to the contrast scan, unless there is a contraindication to the intravenous dye.
The investigators own database search has shown that radiologists protocol the scans according to their own preference and experience (i.e. some do both scans, others the contrast scan only). There is conflicting advice from international professional bodies as to whether to perform the non-contrast scan every time.
Some studies have shown that although the pre-contrast scan is sensitive to picking up bleeding within the wall, it adds nothing more over an increased radiation dose to the patient.
The investigators hypothesise that performing the contrast scan on its own is diagnostically equivalent to both the pre- and contrast scans to look for all 4 of these entities that make up AAS. The investigators also propose that not requiring the pre-contrast scan would have significant savings in patient radiation dose, scanner time, network resources and radiologist time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic aortgram CTs | – | Radiation: Thoracic aortogram CTA retrospective cohort assessment of thoracic aortogram CTs of male and female adult (age>18) patients presenting with symptoms of AAS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective cohort assessment of thoracic aortogram CTs of male and female adult (age>18) patients presenting with symptoms of AAS.
Key inclusion criteria (1 listed)
- male and female adult (age>18) patients presenting with symptoms of AAS who had thoracic aortogram CTs.
Key exclusion criteria (1 listed)
- age<18
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 |
|---|---|---|
| Thoracic aortogram CTWith and without contrast dye | Radiation | thoracic aortgram CTs |
Primary outcome
Blinded review
Time frame: 3 months
2 experienced reporters are asked to blind view, in random order, either a contrast scan only, or a pair of pre- and post-contrast scans and report on an Excel spreadsheet.
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 5 Nov 2015.
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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, MBChB FRCP study director
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 Acute Aortic Syndrome, 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 5 Nov 2015. 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?
Blinded review (time frame: 3 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 5 Nov 2015.