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

NCT05735938 | Terminated

• 1 other identifier: 2022.284
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Acute Chest Pain; Fundas camera; Machine learning; Artificial Intelligence; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Prevalence of adverse cardiac events within 30 days after initial presentation

  30 days

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presented to Emergency Department from Monday to Friday, 9am to 5pm

You may qualify if:

• Patient with chest pain onset within 24 hours, and
• Patient is aged 21 and above

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Accident and Emergency Department, Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Kevin KC Hung, Dr.

  AEMAU, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: August 18, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

HK (1)