Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department (ADD-ED)

April 15, 2024 updated by: Colin Graham, Chinese University of Hong Kong

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
    • NT
      • Sha Tin, NT, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Colin A Graham, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of D-Dimer, Aggrecan and Desmosine
Time Frame: Blood samples taken preoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 2022.631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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