Use of ARIA in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome - Trial NCT05735938

Timeline & Enrollment

Primary Outcome

Prevalence of adverse cardiac events within 30 days after initial presentation

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.

ICD-10 Classifications