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

NCT07640334 | Not Yet Recruiting DMC

• 1 other identifier: ADD-RS_D-dimer_Protocol_PWH_v1
• Study Type: observational
• Target: 448
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Aortic Syndrome

Outcome Measures

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

  number of patients with ADD-RS \<2 and a negative D-dimer who were actually AAS cases

  From enrollment to 30 days after index visit

Secondary Outcomes (1)

• sensitivity of the proposed algorithm

  From enrolment to 30 days after the index visit

Other Outcomes (3)

• D-dimer levels in different subgroups

  After completion of recruitment, estimated 18 months

• Hospital length of stay

  From enrolment to 30 day follow-up

• proportion of patients undergoing CT imaging

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the ED meeting the above criteria during the recruitment timeframe

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Acute Aortic Syndrome

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Colin Graham, Professor

CONTACT

+852 35051698; cagraham@cuhk.edu.hk

Rebecca Li, Miss

CONTACT

35051698

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 13, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)