Acute Coronary SyndromeNCT05735938
Use of ARIA in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 76 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Aug 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented to Emergency Department from Monday to Friday, 9am to 5pm
Who may be able to join
- Patient with chest pain onset within 24 hours, and
- Patient is aged 21 and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Accident and Emergency Department, Prince of Wales Hospital
Shatin
About this study
Official title: Use of Automtic Retinal Image Analysis in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome
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:
Read more
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
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of adverse cardiac events within 30 days after initial presentation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start18 Aug 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: Lack of manpower
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin HUNG Kei-ching, Chinese University of Hong Kong
- Investigators
- Kevin KC Hung, Dr., Principal investigator, AEMAU, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735938
- Sponsor's protocol ID
- 2022.284
- Status last verified
- Aug 2024
- First submitted
- 10 Feb 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Automtic Retinal Image Analysis in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05735938
- Acronym / sponsor ID
- 2022.284
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Acute Chest Pain, Fundas camera, Machine learning, Artificial Intelligence, Risk Stratification
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of manpower
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented to Emergency Department from Monday to Friday, 9am to 5pm
Key inclusion criteria (2 listed)
- Patient with chest pain onset within 24 hours, and
- Patient is aged 21 and above
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of adverse cardiac events within 30 days after initial presentation
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Lack of manpower). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin KC Hung, Dr. principal investigator
AEMAU, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of manpower). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of adverse cardiac events within 30 days after initial presentation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.