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临床试验/NCT05582967
NCT05582967已完成不适用

An Observational Cohort Study of People Attending the ED With Symptoms of Acute Aortic Syndrome (AAS)

NHS Lothian25 个研究点 分布在 1 个国家目标入组 5,548 人开始时间: 2022年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
NHS Lothian
入组人数
5,548
试验地点
25
主要终点
Median time from hospital presentation to imaging diagnosis and median time from symptom onset to hospital presentation (hours)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • No symptoms of AAS.
  • <16 years old

结局指标

主要结局

Median time from hospital presentation to imaging diagnosis and median time from symptom onset to hospital presentation (hours)

时间窗: 30 days

Median time from hospital presentation to imaging diagnosis and median time from symptom onset to hospital presentation (hours)

Enrolment rate at each participating site

时间窗: 30 days

Number of participants during study period enrolled

Test characteristics of Canadian guideline score

时间窗: 30 days

Test characteristics of Canadian guideline score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)

Number of AAS patients not enrolled due to lack of clinical/research support

时间窗: 30 days

Number of AAS patients not enrolled due to lack of clinical/research support

Test characteristics Aorta score

时间窗: 30 days

Test characteristics of Aorta score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)

Proportion of patients in whom the ED clinician thinks Acute Aortic Syndrome (AAS) is a possible differential who have confirmed AAS

时间窗: 30 days

Proportion of patients in whom the ED clinician thinks Acute Aortic Syndrome (AAS) is a possible differential who have confirmed AAS

CT angiogram (CTA) ordering and positivity rate

时间窗: 30 days

Number of CT angiograms ordered and the proportion that are positive scans

Test characteristics of Sheffield AAS decision rule

时间窗: 30 days

Test characteristics of Sheffield AAS decision rule (i.e. sensitivity, specificity, positive predictive value, negative predictive value)

Proportion of patients in whom ED clinician considers AAS NOT a possible differential who had confirmed AAS

时间窗: 30 days

Proportion of patients in whom ED clinician considers AAS NOT a possible differential who had confirmed AAS

Test characteristics of clinical acumen

时间窗: 30 days

Test characteristics of clinical acumen (i.e. sensitivity, specificity, positive predictive value, negative predictive value)

Test characteristics of D-dimer

时间窗: 30 days

Test characteristics of D-dimer (i.e. sensitivity, specificity, positive predictive value, negative predictive value)

30-day mortality in proven AAS

时间窗: 30 days

30-day mortality in proven AAS

Proportion of alternative diagnoses found on CTA and final hospital diagnosis

时间窗: 30 days

Proportion of alternative diagnoses found on CTA and final hospital diagnosis

Test characteristics of ADD-RS (Aortic Dissection Detection-Risk Score)

时间窗: 30 days

Test characteristics of Aortic Dissection Detection-Risk Score (i.e. sensitivity, specificity, positive predictive value, negative predictive value)

Number of patients not able to be enrolled with reason why not enrolled

时间窗: 30 days

Number of patients not able to be enrolled with reason why not enrolled

次要结局

未报告次要终点

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

研究点 (25)

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