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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Aortic Syndrome
• Intervention / Treatment: Diagnostic test: D-dimer test

• Study Type: Observational
• Enrollment (Estimated): 448

Contacts and Locations

• Study Contact: Name: Colin Graham, Professor; Phone Number: +852 35051698; Email: cagraham@cuhk.edu.hk
• Study Contact Backup: Name: Rebecca Li, Miss; Phone Number: 35051698

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital
    • Contact: Rebecca Li; Phone Number: 35051698

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity of the proposed algorithm	The sensitivity of using ADD-RS and D-dimer to rule out AAS without performing CTA in the ED	From enrolment to 30 days after the index visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After completion of recruitment, estimated 18 months
Hospital length of stay	The number of days for patients staying in the hospital	From enrolment to 30 day follow-up
proportion of patients undergoing CT imaging	the percentage of patients underwent CT imaging in the ED	From enrolment til patient discharged from the ED, estimated within the day of enrolment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Prince of Wales Hospital, Shatin, Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): July 13, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome
• Other Study ID Numbers: ADD-RS_D-dimer_Protocol_PWH_v1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collected from this study is exclusively for our own institutional research purpose.

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No