Clincosm LogoSign in Get a demo

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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT06065306
Collaborator
(none)
47
Enrollment
1
Location
30.5
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    47 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department: the Aggrecan, Desmosine, D-dimer-Emergency Department (ADD-ED) Study
    Actual Study Start Date :
    Jun 18, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. the diagnosis of AD adjudicated by an independent expert panel, hospital discharge or death, whichever comes first [7 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Exclusion Criteria:

    • Age <18 years old

    • Pregnancy

    • Surgery or stenting performed before recruitment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Sha Tin NT Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Colin Graham, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT06065306
    Other Study ID Numbers:
    • CREC 2022.631
    First Posted:
    Oct 3, 2023
    Last Update Posted:
    Oct 3, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Colin Graham, Professor, Chinese University of Hong Kong
    aortic dissection
    biomarker
    diagnostic
    d-dimer
    aggrecan
    desmosine
    Additional relevant MeSH terms:
    Aortic Dissection
    Emergencies

    Study Results

    No Results Posted as of Oct 3, 2023