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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
From enrollment to 30 days after index visit

Secondary outcomes

1

sensitivity of the proposed algorithm

The sensitivity of using ADD-RS and D-dimer to rule out AAS without performing CTA in the ED

Time frame
From enrolment to 30 days after the index visit

Other outcomes

1

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.

Time frame
After completion of recruitment, estimated 18 months
2

Hospital length of stay

The number of days for patients staying in the hospital

Time frame
From enrolment to 30 day follow-up
3

proportion of patients undergoing CT imaging

the percentage of patients underwent CT imaging in the ED

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

Sponsors and contacts

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Chinese University of Hong Kong

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Collaborator

This trial is not recruiting at the moment. You can still explore other options: