Aortic DissectionDAShEDNCT05582967
The DAShED (Diagnosis of Aortic Syndrome in the ED) Study
An observational study of Aortic Dissection, run by NHS Lothian at 25 sites in United Kingdom.
Trial summary
Acute aortic syndrome (AAS) is a life-threatening emergency condition affecting the upper aorta affecting ~4000 people in the (United Kingdom; UK) a year with an ED misdiagnosis rate as high as 38%. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Completion of focused Electronic Case Report Form
- How many people
- 5,548 participants
- Where
- 25 sitesUnited Kingdom
- Study dates
- 26 Sep 2022to 21 Jan 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All people attending the Emergency Department (ED) with symptoms of possible AAS, including new-onset chest, back or abdominal pain, syncope or symptoms related to malperfusion.
Who may be able to join
- People attending the ED with symptoms of AAS, including those with new-onset chest, back or abdominal pain, syncope or symptoms related to malperfusion.
- ≥16 years old
Who cannot join
- No symptoms of AAS.
- <16 years old
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United Kingdom25 sites
Royal United Hospital
Bath
Bristol Royal Infirmary
Bristol
North Bristol NHS Trust
Bristol
Addenbrookes hospital
Cambridge
Royal Infirmary of Edinburgh
Edinburgh
St Johns Hospital
Edinburgh
Frimley Health
Frimley
Queen Elizabeth University Hospital
Glasgow
Royal Alexandra Hospital
Glasgow
James Paget University Hospital
Great Yarmouth
Harrogate
Harrogate
Raigmore
Inverness
Queen Elizabeth Hospital NHS Foundation Trust
Kings Lynn
Victoria Hospital
Kirkcaldy
Lewisham and Greenwich NHS Trust
Lewisham
Luton & Dunstable University Hospital
Luton
Wythenshawe Hospital
Manchester
Milton Keynes Universoty Hospital NHS Foundation Trust
Milton Keynes
Royal Victoria Infirmary
Newcastle
Royal Oldham Hospital
Oldham
John Radcliffe Hospital
Oxford
Royal Glamorgan Hospital
Pont-y-clun
Royal Berkshire NHS Foundation Trust
Reading
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Wexham Park
Slough
About this study
Official title: An Observational Cohort Study of People Attending the ED With Symptoms of Acute Aortic Syndrome (AAS)
Acute aortic syndrome (AAS) is a life-threatening emergency condition affecting the upper aorta affecting ~4000 people in the (United Kingdom; UK) a year with an ED misdiagnosis rate as high as 38%. Previous research has identified several strategies combining clinical probability scoring with blood tests (D-Dimer) to rule out the condition but when applied to a large population (ED) with relatively low numbers of actual cases, these result in a high rate of computed tomographic angiography (CTA) scanning. Current guidelines reflect the uncertainty of existing evidence.
This study, the first phase of three, aims to describe the characteristics of ED attendances with possible AAS, to determine the service implications of using different diagnostic strategies and inform future research. The investigators plan to recruit all ED attendances with possible AAS over a 1-4 week period. The investigators plan a prospective and retrospective approach to data collection adopting a waived-consent strategy with endpoint measures describing the characteristics of patients presenting with possible AAS.
Read the detailed description
AAS is a life-threatening emergency condition which presents to the ED. Around 4,000 people suffer per year in the UK [1], many not receiving timely diagnosis and treatment. 25% of patients are not diagnosed until 24 hours after arriving in the ED due to the varied nature of presentation [2]. Chest pain is the most common presenting symptom of AAS (80%) although back pain (40%) and abdominal pain are not uncommon [1]. These symptoms account for over 2 million ED attendances per year in England [National Health Service; NHS Digital A\&E 2021] and are overwhelmingly due to causes other than AAS. The estimated incidence of AAS is 1 in every 980 ED attendances with atraumatic chest pain [3], thus creating a substantial diagnostic challenge.
Prognosis is best when patients are treated early, and mortality increases 2% per hour of delay. [4] The misdiagnosis rate during the initial ED visit for AAS is estimated to be between 1 in 3 to 1 in 7 AASs [5], leading to worse outcomes [6,7] whilst CTA over testing leads to diagnostic yields as low as 2-3%. [2,8]. CTA scanning of the aorta has high sensitivity and specificity for diagnosing AAS, but an unrestricted CT strategy will incur significant costs, has ionising radiation risks, resource implications, CT delays for non-AAS patients and the burden of 'incidentalomas'.
Clinicians therefore need to use CTA selectively but there is no validated scoring system to help this decision. Several have been proposed [1, 9-14] including the ADD-RS score, the Canadian clinical practice guideline Clinical Decision Aid [13], the AORTAs score [14] and the Sheffield score [unpublished]. D-Dimer has been suggested as a rule-out biomarker in low pre-test probability patients (95-98% sensitivity) [15,16] and has been incorporated into the Aortic Dissection Detection-Risk Stratification (ADD-RS) score to reduce CTA rate in low pre-test probability patients. None have been studied in truly undifferentiated ED populations, or in the UK where CTA threshold is different compared to North America. It is currently unclear whether any have sufficient sensitivity to be acceptable to clinicians, which is the most accurate, and whether they are likely to lead to CTA and D-Dimer over testing. Assessment of CTA rate and CT positivity has also not previously been studied. The Royal College of Emergency Medicine has recently released a national guideline advocating any patient with an ADD-RS score of >=1 (no D-dimer incorporated) should have a CT aorta performed (unless other cause for symptoms identified and evidenced). The recommendation is not based on UK-validated clinical evidence, however, and clinical impacts of the recommendation are yet to be seen.
In view of these diagnostic challenges, the investigators aim in our programme of work to ultimately to assess which of the four aforementioned clinical decision tools is most effective, assess external validity, and assess clinical impact. This study (Phase 1; DAShED) will involve prospective data collection on all characteristics of four different risk scores, in addition to evaluation of patient characteristics, potential CT aorta rates with different strategies, and enrolment rates at participating sites. This will inform Phase 2, which will involve full interventional external validation study of the decision aid(s) selected in Phase 1 (including biomarker collection); the main objective being to select the score to subject to assessment of clinical impact (intervention step-wedge trial) in Phase 3.
This is an observational cohort study of all people attending the ED with symptoms of possible AAS, including new-onset chest, back or abdominal pain, syncope or symptoms related to malperfusion.
- Conditions
- Aortic Dissection
- Being tested
- Completion of focused Electronic Case Report Form
- Keywords
- Aortic Dissection, Diagnostic accuracy, Aorta, Emergency, Diagnosis
- Medical subject headings
- Aortic Dissection, Emergencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of focused Electronic Case Report FormOther
All patients will have a focussed Electronic Case Report Form completed collecting information around Presenting complaint, Past Medical History, Family History, Physical Examination findings, and Investigations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrolment rate at each participating site
Number of participants during study period enrolled
Measured: 30 days
Proportion of patients in whom the ED clinician thinks Acute Aortic Syndrome (AAS) is a possible differential who have confirmed AAS
Proportion of patients in whom the ED clinician thinks Acute Aortic Syndrome (AAS) is a possible differential who have confirmed AAS
Measured: 30 days
Proportion of patients in whom ED clinician considers AAS NOT a possible differential who had confirmed AAS
Proportion of patients in whom ED clinician considers AAS NOT a possible differential who had confirmed AAS
Measured: 30 days
Number of AAS patients not enrolled due to lack of clinical/research support
Number of AAS patients not enrolled due to lack of clinical/research support
Measured: 30 days
CT angiogram (CTA) ordering and positivity rate
Number of CT angiograms ordered and the proportion that are positive scans
Measured: 30 days
Test characteristics of clinical acumen
Test characteristics of clinical acumen (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Measured: 30 days
Test characteristics of ADD-RS (Aortic Dissection Detection-Risk Score)
Test characteristics of Aortic Dissection Detection-Risk Score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Measured: 30 days
Test characteristics Aorta score
Test characteristics of Aorta score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Measured: 30 days
Test characteristics of Canadian guideline score
Test characteristics of Canadian guideline score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Measured: 30 days
Test characteristics of Sheffield AAS decision rule
Test characteristics of Sheffield AAS decision rule (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Measured: 30 days
Test characteristics of D-dimer
Test characteristics of D-dimer (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Measured: 30 days
Median time from hospital presentation to imaging diagnosis and median time from symptom onset to hospital presentation (hours)
Median time from hospital presentation to imaging diagnosis and median time from symptom onset to hospital presentation (hours)
Measured: 30 days
30-day mortality in proven AAS
30-day mortality in proven AAS
Measured: 30 days
Proportion of alternative diagnoses found on CTA and final hospital diagnosis
Proportion of alternative diagnoses found on CTA and final hospital diagnosis
Measured: 30 days
Number of patients not able to be enrolled with reason why not enrolled
Number of patients not able to be enrolled with reason why not enrolled
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start26 Sep 2022
- Primary completion21 Jan 2023
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies 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
- Prospective
- Enrolment
- 5,548 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Rachel McLatchie, Principal investigator, Accord Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582967
- Sponsor's protocol ID
- AC22083
- Other IDs
- 22/PR/0807, 315948
- Acronym
- DAShED
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared on request
Publications
McLatchie R, Reed MJ, Freeman N, Parker RA, Wilson S, Goodacre S, Cowan A, Boyle J, Clarke B, Clarke E; DAShED investigators. Diagnosis of Acute Aortic Syndrome in the Emergency Department (DAShED) study: an observational cohort study of people attending the emergency department with symptoms consistent with acute aortic syndrome. Emerg Med J. 2024 Feb 20;41(3):136-144. doi: 10.1136/emermed-2023-213266.
PubMed 37945311
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study of People Attending the ED With Symptoms of Acute Aortic Syndrome (AAS)
- ClinicalTrials.gov ID
- NCT05582967
- Acronym / sponsor ID
- DAShED / AC22083
- Conditions
- Aortic Dissection
- Keywords
- Aortic Dissection, Diagnostic accuracy, Aorta, Emergency, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,548 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- University of Edinburgh
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- 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 life-threatening emergency condition affecting the upper aorta affecting ~4000 people in the (United Kingdom; UK) a year with an ED misdiagnosis rate as high as 38%. Previous research has identified several strategies combining clinical probability scoring with blood tests (D-Dimer) to rule out the condition but when applied to a large population (ED) with relatively low numbers of actual cases, these result in a high rate of computed tomographic angiography (CTA) scanning. Current guidelines reflect the uncertainty of existing evidence.
This study, the first phase of three, aims to describe the characteristics of ED attendances with possible AAS, to determine the service implications of using different diagnostic strategies and inform future research. The investigators plan to recruit all ED attendances with possible AAS over a 1-4 week period. The investigators plan a prospective and retrospective approach to data collection adopting a waived-consent strategy with endpoint measures describing the characteristics of patients presenting with possible AAS.
Detailed description
AAS is a life-threatening emergency condition which presents to the ED. Around 4,000 people suffer per year in the UK [1], many not receiving timely diagnosis and treatment. 25% of patients are not diagnosed until 24 hours after arriving in the ED due to the varied nature of presentation [2]. Chest pain is the most common presenting symptom of AAS (80%) although back pain (40%) and abdominal pain are not uncommon [1]. These symptoms account for over 2 million ED attendances per year in England [National Health Service; NHS Digital A\&E 2021] and are overwhelmingly due to causes other than AAS. The estimated incidence of AAS is 1 in every 980 ED attendances with atraumatic chest pain [3], thus creating a substantial diagnostic challenge.
Prognosis is best when patients are treated early, and mortality increases 2% per hour of delay. [4] The misdiagnosis rate during the initial ED visit for AAS is estimated to be between 1 in 3 to 1 in 7 AASs [5], leading to worse outcomes [6,7] whilst CTA over testing leads to diagnostic yields as low as 2-3%. [2,8]. CTA scanning of the aorta has high sensitivity and specificity for diagnosing AAS, but an unrestricted CT strategy will incur significant costs, has ionising radiation risks, resource implications, CT delays for non-AAS patients and the burden of 'incidentalomas'.
Clinicians therefore need to use CTA selectively but there is no validated scoring system to help this decision. Several have been proposed [1, 9-14] including the ADD-RS score, the Canadian clinical practice guideline Clinical Decision Aid [13], the AORTAs score [14] and the Sheffield score [unpublished]. D-Dimer has been suggested as a rule-out biomarker in low pre-test probability patients (95-98% sensitivity) [15,16] and has been incorporated into the Aortic Dissection Detection-Risk Stratification (ADD-RS) score to reduce CTA rate in low pre-test probability patients. None have been studied in truly undifferentiated ED populations, or in the UK where CTA threshold is different compared to North America. It is currently unclear whether any have sufficient sensitivity to be acceptable to clinicians, which is the most accurate, and whether they are likely to lead to CTA and D-Dimer over testing. Assessment of CTA rate and CT positivity has also not previously been studied. The Royal College of Emergency Medicine has recently released a national guideline advocating any patient with an ADD-RS score of >=1 (no D-dimer incorporated) should have a CT aorta performed (unless other cause for symptoms identified and evidenced). The recommendation is not based on UK-validated clinical evidence, however, and clinical impacts of the recommendation are yet to be seen.
In view of these diagnostic challenges, the investigators aim in our programme of work to ultimately to assess which of the four aforementioned clinical decision tools is most effective, assess external validity, and assess clinical impact. This study (Phase 1; DAShED) will involve prospective data collection on all characteristics of four different risk scores, in addition to evaluation of patient characteristics, potential CT aorta rates with different strategies, and enrolment rates at participating sites. This will inform Phase 2, which will involve full interventional external validation study of the decision aid(s) selected in Phase 1 (including biomarker collection); the main objective being to select the score to subject to assessment of clinical impact (intervention step-wedge trial) in Phase 3.
This is an observational cohort study of all people attending the ED with symptoms of possible AAS, including new-onset chest, back or abdominal pain, syncope or symptoms related to malperfusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All people attending the Emergency Department (ED) with symptoms of possible AAS, including new-onset chest, back or abdominal pain, syncope or symptoms related to malperfusion.
Key inclusion criteria (2 listed)
- People attending the ED with symptoms of AAS, including those with new-onset chest, back or abdominal pain, syncope or symptoms related to malperfusion.
- ≥16 years old
Key exclusion criteria (2 listed)
- No symptoms of AAS.
- <16 years old
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 |
|---|---|---|
| Completion of focused Electronic Case Report FormAll patients will have a focussed Electronic Case Report Form completed collecting information around Presenting complaint, Past Medical History, Family History, Physical Examination findings, and Investigations. | Other | – |
Primary outcome
Enrolment rate at each participating site
Time frame: 30 days
Number of participants during study period enrolled
Proportion of patients in whom the ED clinician thinks Acute Aortic Syndrome (AAS) is a possible differential who have confirmed AAS
Time frame: 30 days
Proportion of patients in whom the ED clinician thinks Acute Aortic Syndrome (AAS) is a possible differential who have confirmed AAS
Proportion of patients in whom ED clinician considers AAS NOT a possible differential who had confirmed AAS
Time frame: 30 days
Proportion of patients in whom ED clinician considers AAS NOT a possible differential who had confirmed AAS
Number of AAS patients not enrolled due to lack of clinical/research support
Time frame: 30 days
Number of AAS patients not enrolled due to lack of clinical/research support
CT angiogram (CTA) ordering and positivity rate
Time frame: 30 days
Number of CT angiograms ordered and the proportion that are positive scans
Test characteristics of clinical acumen
Time frame: 30 days
Test characteristics of clinical acumen (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Test characteristics of ADD-RS (Aortic Dissection Detection-Risk Score)
Time frame: 30 days
Test characteristics of Aortic Dissection Detection-Risk Score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Test characteristics Aorta score
Time frame: 30 days
Test characteristics of Aorta score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Test characteristics of Canadian guideline score
Time frame: 30 days
Test characteristics of Canadian guideline score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Test characteristics of Sheffield AAS decision rule
Time frame: 30 days
Test characteristics of Sheffield AAS decision rule (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Test characteristics of D-dimer
Time frame: 30 days
Test characteristics of D-dimer (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
Median time from hospital presentation to imaging diagnosis and median time from symptom onset to hospital presentation (hours)
Time frame: 30 days
Median time from hospital presentation to imaging diagnosis and median time from symptom onset to hospital presentation (hours)
30-day mortality in proven AAS
Time frame: 30 days
30-day mortality in proven AAS
Proportion of alternative diagnoses found on CTA and final hospital diagnosis
Time frame: 30 days
Proportion of alternative diagnoses found on CTA and final hospital diagnosis
Number of patients not able to be enrolled with reason why not enrolled
Time frame: 30 days
Number of patients not able to be enrolled with reason why not enrolled
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 23 Mar 2023.
- Derived from this study: PubMed 37945311McLatchie R, Reed MJ, Freeman N, Parker RA, Wilson S, Goodacre S, Cowan A, Boyle J, Clarke B, Clarke E; DAShED investigators. Diagnosis of Acute Aortic Syndrome in the Emergency Department (DAShED) study: an observational cohort study of people attending the emergency department with symptoms consistent with acute aortic syndrome. Emerg Med J. 2024 Feb 20;41(3):136-144. doi: 10.1136/emermed-2023-213266.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data may be shared on request
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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.
Rachel McLatchie principal investigator
Accord Clinical Research
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by NHS Lothian at 25 sites 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 2 inclusion and 2 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
Enrolment rate at each participating site (time frame: 30 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05582967, which also lists 1 linked publication.
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 23 Mar 2023.