Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome

NCT07640334 — Recruiting, 746 participants, Chinese University of Hong Kong

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The Combination of Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome: Multicentre Prospective Study in Emergency Departments

Registry	NCT07640334
Status	Recruiting
Study type	Observational
Enrollment	746 (Estimated)
Sponsor	Chinese University of Hong Kong (Other); collaborators: Prince of Wales Hospital, Shatin, Hong Kong
Conditions	Acute Aortic Syndrome
Interventions	D-dimer test (Diagnostic test)
Dates	start 2026-08-11, primary completion 2028-06-30 (estimated), completion 2028-12-31 (estimated), first posted 2026-06-10, last updated 2026-10-21
Locations	2 sites in Hong Kong

-Summary

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.

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+Arms and interventions

D-dimer test (Diagnostic test): The 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.

+Outcome measures

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 [From enrollment to 30 days after index visit]: number of patients with ADD-RS <2 and a negative D-dimer who were actually AAS cases

Secondary outcomes

sensitivity of the proposed algorithm [From enrolment to 30 days after the index visit]: 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 [After completion of recruitment, estimated 18 months]: D-dimer levels will be compared across different subgroups of AAS, including aortic dissection ,intramural hematoma and penetrating aortic ulcer.
Hospital length of stay [From enrolment to 30 day follow-up]: The number of days for patients staying in the hospital
proportion of patients undergoing CT imaging [From enrolment til patient discharged from the ED, estimated within the day of enrolment]: the percentage of patients underwent CT imaging in the ED

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Patient who refuse to participate.

+Locations (2)

Facility	City	Country	Status
Accident and Emergency Department, Queen Mary Hospital	Hong Kong	Hong Kong	Not yet recruiting
Prince of Wales Hospital	Shatin	Hong Kong	Recruiting