Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05735938
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2023-02-10
Brief Title:
Use of ARIA in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Use of Automtic Retinal Image Analysis in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of manpower
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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 hisher 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 hisher inital ED visit
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 subjects 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 hisher 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 hisher inital ED visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None