Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department

NCT06065306 | Recruiting

• 1 other identifier: CREC 2022.631
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  Blood samples taken preoperatively

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years old
• Pregnancy
• Surgery or stenting performed before recruitment

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, NT, Hong Kong

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Disease

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Colin A Graham

CONTACT

+85235051033; cagraham@cuhk.edu.hk

Theresa Hui

CONTACT

+85235051698; theresahui@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 3, 2023
• Study Start: June 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

HK (1)