Use of ARIA in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Suspended
CT.gov ID
NCT05735938
Collaborator
(none)
420
1
23.5
17.9

Study Details

Study Description

Brief Summary

The current assessment of patients with acute chest pain in the Emergency Department (ED) remains lengthy with the need for serial troponin. This contributes to overcrowding in the ED and work overload of clinical staff. These are associated with increased costs and adverse patient outcomes. The use of risk scores such at HEART score can be subjective and is not useful in risk stratification for those with higher risk (age and risk factors) to Major Acute Cardiac Event (MACE).

Aim of Study:

This study is designed to explore whether the use of Automatic Retinal Image Analysis (ARIA) can identify patients presenting with undifferentiated chest pain without the need for serial troponin test results in order to facilitate early and safely discharge and at high-risk MACE to receive early appropriate intervention.

Hypothesis:

ARIA or the combination with single troponin or HEART score can identify patients with undifferentiated chest pain presenting to the ED at low- and high-risk of adverse cardiac events within 30 days and 3 months after initial presentation.

Procedure:

The ARIA is a non-invasive and novel technology, it will be used to access the risk of acute coronary syndrome by analyzing of fundus (back of the eye) photo taken by a fundus camera. All subjects will be arranged to take a fundus photography (both eyes) by a conventional fundus camera, and capture the retinal photo. The images will be used to develop a risk stratification method for chest pain patients presenting to ED with suspected acute coronary syndrome (ACS). The fundus photography will be taken in the Emergency Department of Prince of Wales Hospital. The process takes about 5-8 minutes. Subject may feel discomfort for a short while at the time of photo taking due to flash exposure similar to ordinary camera flash, but the procedure is neither invasive nor painful. The fundus image will then be analyzed by computer algorithm developed by the research team. Apart from that, subject's medical history, ECG findings, age and sex, risk factors, and serial troponin levels will be recorded during their ED visit in order to work out the HEART score. Their disposal outcome from the ED will also be recorded. After 30 days, subject will be phoned to follow-up whether they have been readmitted into the hospital. If the subject have been readmitted, his/her investigation findings, diagnosis, treatment, disposal outcome, and length-of-stay will be recorded. The same follow-up process will be performed once more at 3 months after the subject has joined the study in his/her inital ED visit.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    420 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Use of Automtic Retinal Image Analysis in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome
    Actual Study Start Date :
    Aug 18, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of adverse cardiac events within 30 days after initial presentation [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with chest pain onset within 24 hours, and

    • Patient is aged 21 and above

    Exclusion Criteria:
    • Patient's chest pain condition does not require ECG or/and troponin investigation

    • Patient requires resuscitation

    • Patient requires cardiologist consultation or intervention

    • Patient has cataract or other eye disease which affects fundus photography

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Accident and Emergency Department, Prince of Wales Hospital Sha Tin Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Kevin KC Hung, Dr., AEMAU, The Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kevin HUNG Kei-ching, Assistant Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05735938
    Other Study ID Numbers:
    • 2022.284
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kevin HUNG Kei-ching, Assistant Professor, Chinese University of Hong Kong
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2023