The DAShED (Diagnosis of Aortic Syndrome in the ED) Study
DAShED
An Observational Cohort Study of People Attending the ED With Symptoms of Acute Aortic Syndrome (AAS)
3 other identifiers
observational
5,548
1 country
25
Brief 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%. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Shorter than P25 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2022
CompletedFirst Submitted
Initial submission to the registry
October 10, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2023
CompletedMarch 23, 2023
October 1, 2022
4 months
October 10, 2022
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Enrolment rate at each participating site
Number of participants during study period enrolled
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
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
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
30 days
CT angiogram (CTA) ordering and positivity rate
Number of CT angiograms ordered and the proportion that are positive scans
30 days
Test characteristics of clinical acumen
Test characteristics of clinical acumen (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
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)
30 days
Test characteristics Aorta score
Test characteristics of Aorta score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
30 days
Test characteristics of Canadian guideline score
Test characteristics of Canadian guideline score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
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)
30 days
Test characteristics of D-dimer
Test characteristics of D-dimer (i.e. sensitivity, specificity, positive predictive value, negative predictive value)
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)
30 days
30-day mortality in proven AAS
30-day mortality in proven AAS
30 days
Proportion of alternative diagnoses found on CTA and final hospital diagnosis
Proportion of alternative diagnoses found on CTA and final hospital diagnosis
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
30 days
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- No symptoms of AAS.
- \<16 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Lothianlead
- University of Edinburghcollaborator
Study Sites (25)
Royal United Hospital
Bath, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Addenbrookes hospital
Cambridge, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
St Johns Hospital
Edinburgh, United Kingdom
Frimley Health
Frimley, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Royal Alexandra Hospital
Glasgow, United Kingdom
James Paget University Hospital
Great Yarmouth, United Kingdom
Harrogate
Harrogate, United Kingdom
Raigmore
Inverness, United Kingdom
Queen Elizabeth Hospital NHS Foundation Trust
Kings Lynn, United Kingdom
Victoria Hospital
Kirkcaldy, United Kingdom
Lewisham and Greenwich NHS Trust
Lewisham, United Kingdom
Luton & Dunstable University Hospital
Luton, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
Milton Keynes Universoty Hospital NHS Foundation Trust
Milton Keynes, United Kingdom
Royal Victoria Infirmary
Newcastle, United Kingdom
Royal Oldham Hospital
Oldham, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Royal Glamorgan Hospital
Pont-y-clun, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Wexham Park
Slough, United Kingdom
Related Publications (1)
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.
PMID: 37945311DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel McLatchie
Accord Clinical Research
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 17, 2022
Study Start
September 26, 2022
Primary Completion
January 21, 2023
Study Completion
January 21, 2023
Last Updated
March 23, 2023
Record last verified: 2022-10