About this trial
The goal of this study is to evaluate the safety of integrating the Aortic Dissection Detection Risk Score (ADD-RS) and D-dimer testing for ruling out acute aortic syndrome (AAS) in the emergency department (ED). The main question it aims to answer: Can the combination of the ADD-RS \<2, and D dimer \<500ng/mL rule-out AAS in ED patients without CTA? The researchers will recruit patients suspected with AAS in the ED, and the patients will receive a ADD-RS score, a D-dimer testing after signing a written consent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged ≥ 18 years; AND
Presentation to the ED with any of the following symptoms: acute onset (<14 days) chest pain, abdominal pain, back pain, syncope, or signs of malperfusion (e.g. limb ischemia, neurological deficit); AND
AAS is considered as a possible differential diagnosis by the treating physician. Enrolment in the study will be determined by the attending physician during initial medical consultation in the ED and prior to establishing a final diagnosis.
Disqualifiers
An alternative diagnosis to AAS established by the treating physician after the initial assessment; OR
Trauma cases; OR
Patients with a known diagnosis of AAS before the index ED visit (e.g. with a diagnostic imaging done before the ED visit or referral from other institutions for AAS); OR
Clinical severity or other conditions not allowing complete evaluation/proper enrolment; OR
Trial population
Patients presenting to the ED meeting the above criteria during the recruitment timeframe
Trial design
Cohort
Prospective
Treatments tested in this trial
D-dimer test
Diagnostic testThe patient will receive a ADD-RS calculated by the clinician, evaluating high-risk conditions, high-risk pain features and high-risk physical signs of AAS. A point-of-care D-dimer test will be performed after routine blood taking. The research personnel will collect the above data from the clinician.
Treatment groups
Trial outcomes
Primary outcomes
incidence of missed AAS within 30 days among patients identified as low risk (ADD-RS <2 and D-dimer <500 ng/mL) who did not undergo CTA
number of patients with ADD-RS \<2 and a negative D-dimer who were actually AAS cases
Secondary outcomes
sensitivity of the proposed algorithm
The sensitivity of using ADD-RS and D-dimer to rule out AAS without performing CTA in the ED
Other outcomes
D-dimer levels in different subgroups
D-dimer levels will be compared across different subgroups of AAS, including aortic dissection ,intramural hematoma and penetrating aortic ulcer.
Hospital length of stay
The number of days for patients staying in the hospital
proportion of patients undergoing CT imaging
the percentage of patients underwent CT imaging in the ED
Sponsors and contacts
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Chinese University of Hong Kong
Lead sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Collaborator
This trial is not recruiting at the moment. You can still explore other options: