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NCT Number: NCT07640334

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

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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Key information

Conditions

Acute Aortic Syndrome Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Accident and Emergency Department, Queen Mary Hospital, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    Time frame: 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

  1. sensitivity of the proposed algorithm

    Time frame: 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

  1. D-dimer levels in different subgroups

    Time frame: 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.

  2. Hospital length of stay

    Time frame: From enrolment to 30 day follow-up

    The number of days for patients staying in the hospital

  3. proportion of patients undergoing CT imaging

    Time frame: From enrolment til patient discharged from the ED, estimated within the day of enrolment

    the percentage of patients underwent CT imaging in the ED

Study contacts

Contact information is provided by the study sponsor or research team.

Colin Graham, Professor

CONTACT

[email protected]

+852 35051698

Rebecca Li, Miss

CONTACT

35051698

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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