Aortic DissectionADD-EDNCT06065306
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
An observational study of Aortic Dissection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this observational study is to determine the utility of desmosine, D-dimer and aggrecan as early diagnostic biomarkers in aortic dissection. The main questions it aims to answer are: To investigate the plasma levels of selected biomarkers in ED patients with confirmed aortic dissection To study the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Dissection
- How many people
- 47 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Jun 2023to 31 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 years or above, with AD presenting to the ED within the first 24 hours of symptom onset will be recruited.
Who may be able to join
- Age ≥ 18 years
- Presentation to the ED with first 24 hours of symptoms suggesting AD, including chest pain, upper back pain, syncope of unknown cause, symptoms of any acute perfusion deficit
- Confirmed AD
- the diagnosis of AD adjudicated by an independent expert panel at hospital discharge or death, whichever comes first
- The expert panel will consist of (1) a specialist in Emergency Medicine and (2) a specialist in Cardiology and (3) a specialist in Cardiothoracic Surgery.
Who cannot join
- Age <18 years old
- Pregnancy
- Surgery or stenting performed before recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, NT
Colin Graham, 35051033, cagraham@cuhk.edu.hk
Theresa Hui, 35051698, theresahui@cuhk.edu.hk
About this study
Official title: Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department: the Aggrecan, Desmosine, D-dimer-Emergency Department (ADD-ED) Study
The goal of this observational study is to determine the utility of desmosine, D-dimer and aggrecan as early diagnostic biomarkers in aortic dissection. The main questions it aims to answer are:
- To investigate the plasma levels of selected biomarkers in ED patients with confirmed aortic dissection
- To study the diagnostic performance of plasma levels of selected biomarkers for aortic dissection
- To study the association between plasma levels of selected biomarkers and clinical outcomes
- Conditions
- Aortic Dissection
- Keywords
- aortic dissection, biomarker, diagnostic, d-dimer, aggrecan, desmosine
- Medical subject headings
- Aortic Dissection, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AD | Patient aged greater than 18, presented to the ED with first 24 hours of symptoms suggesting AD, including chest pain, upper back pain, syncope of unknown cause, symptoms of any acute perfusion deficit and confirmed AD. | |
| Healthy | Patients attending ED who do not have coronary disease, hypertension or aortic disease would be identified as healthy control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of D-Dimer, Aggrecan and Desmosine
Biomarkers :Serum levels of D-Dimer, Aggrecan and Desmosine will be compared in patients with confirmed AD versus age and sex matched healthy controls
Measured: Blood samples taken preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start18 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin Graham, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065306
- Sponsor's protocol ID
- CREC 2022.631
- Acronym
- ADD-ED
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided