Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-dimer test.
- Who it may be relevant to
- Registry conditions: Acute Aortic Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Combination of Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome: Multicentre Prospective Study in Emergency Departments
Overview
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 test D-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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- sensitivity of the proposed algorithm [Time frame: From enrolment to 30 days after the index visit]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 2 centers
- Accident and Emergency Department, Queen Mary Hospital — Hong Kong
- Prince of Wales Hospital — Shatin
Identifiers
NCT: NCT07640334 · ADD-RS_D-dimer_Protocol_PWH_v1