Prince of Wales Hospital
Shatin, Hong Kong
Not Yet Recruiting
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
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 TestThe 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
-
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
-
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
-
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.
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Hospital length of stay
Time frame: From enrolment to 30 day follow-up
The number of days for patients staying in the hospital
-
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.
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
- Jun 10, 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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