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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07640334
Enrollment
448
Registered
2026-06-10
Start date
2026-07-13
Completion date
2028-12-31
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Aortic Syndrome

Brief 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.

Interventions

DIAGNOSTIC_TESTD-dimer 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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER
Prince of Wales Hospital, Shatin, Hong Kong
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 CTAFrom enrollment to 30 days after index visitnumber of patients with ADD-RS \<2 and a negative D-dimer who were actually AAS cases

Secondary

MeasureTime frameDescription
sensitivity of the proposed algorithmFrom enrolment to 30 days after the index visitThe sensitivity of using ADD-RS and D-dimer to rule out AAS without performing CTA in the ED

Countries

Hong Kong

Contacts

CONTACTColin Graham, Professor
cagraham@cuhk.edu.hk+852 35051698
CONTACTRebecca Li, Miss
35051698

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026