跳至主要内容
临床试验/NCT05735938
NCT05735938终止不适用

Use of Automtic Retinal Image Analysis in Risk Stratification for Chest Pain Patients Presenting to Emergency Departments Suspected Acute Coronary Syndrome

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
76
试验地点
1
主要终点
Prevalence of adverse cardiac events within 30 days after initial presentation

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Prevalence of adverse cardiac events within 30 days after initial presentation

时间窗: 30 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin HUNG Kei-ching

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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