Risk Prediction Model in Patients With Suspected Coronary Artery Disease Based on Contemporary Stress Echocardiography Data Using Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,281
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular events (MACE) - composite
研究概览
简要总结
The goal of this observational study is to learn whether combining stress echocardiography (stress echo) results with routine clinical information can better predict important heart outcomes in adults (18+) with chest pain who were assessed for suspected coronary artery disease.
The main questions it aims to answer are:
Can an artificial intelligence / machine learning model using stress echo findings plus clinical factors (such as blood pressure, diabetes, smoking, other health conditions, medications, and body measurements) predict major heart-related events (such as heart attack, stroke, death related to heart disease, or the need for coronary procedures) more accurately than stress echo results alone?
Can the model help identify which patients are most likely to benefit from further invasive assessment and possible coronary revascularisation (for example, a stent or bypass surgery)?
Which combination of stress echo measurements and clinical factors contributes most to risk prediction?
Participants will:
Not be asked to attend extra visits or have additional tests for this study.
Have their existing stress echo reports and routinely collected hospital record data analysed (approximately 3,000 people who previously had dobutamine stress echo at Milton Keynes University Hospital).
In some cases, if outcomes are not fully available from hospital records, the research team may check additional sources (such as GP records, or contacting the patient if appropriate) to confirm whether a major heart-related event occurred.
详细描述
This is a single-centre, retrospective observational study using an existing dataset of pharmacological (dobutamine) stress echocardiography (SE) reports generated within Milton Keynes University Hospital over approximately 15 years, starting from 2002. The SE dataset comprises reports/letters produced by a single, experienced clinician, which reduces inter-observer variability and supports consistent interpretation across the cohort.
Data sources and cohort construction
SE reports (in document format) will be converted into a structured research database. A computer science team will develop a generalisable approach to extract structured variables from the clinical SE reports, building on prior proof-of-concept work demonstrating feasibility of converting these reports into a database.
The dataset includes clinical variables (e.g., cardiovascular risk factors, comorbidities, prescribed medications, and anthropometrics) alongside SE-derived measures (including ischaemia detection and wall motion scoring at rest and peak stress).
Stress echocardiography technique (context for imaging-derived variables)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older at the time of the index stress echocardiography.
- •Referred for pharmacological (dobutamine) stress echocardiography at Milton Keynes University Hospital for assessment of suspected coronary artery disease / chest pain.
- •Stress echocardiography report available in the hospital dataset for data extraction and conversion into a structured database.
排除标准
- •Age under 18 years at the time of the index stress echocardiography.
- •No available/usable stress echocardiography report for extraction into the study database.
- •Unable to link the record to follow-up outcome information using routine hospital systems (with attempted supplementary checks where needed).
- •Patients who have registered a National Data Opt-out and are therefore not eligible for use of their confidential patient information for research/secondary purposes in this study.
研究组 & 干预措施
Dobutamine Stress Echocardiography Cohort
Adults who previously underwent clinically indicated dobutamine stress echocardiography at Milton Keynes University Hospital for assessment of chest pain/suspected coronary artery disease. Stress echocardiography findings and routinely collected clinical information from existing records will be extracted and linked to subsequent cardiovascular outcomes captured through routine care data. Analyses will examine differences in outcomes between participants with normal versus abnormal stress echocardiography findings (and across predicted risk strata generated by the model).
干预措施: Dobutamine Stress Echocardiography (Diagnostic Test)
结局指标
主要结局
Major adverse cardiovascular events (MACE) - composite
时间窗: From the index dobutamine stress echocardiography date until the first major adverse cardiovascular event or death (whichever occurs first), or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).
Composite of fatal myocardial infarction, non-fatal myocardial infarction, stroke, planned coronary revascularisation, and unplanned coronary revascularisation. (yes/no)
次要结局
- fatal myocardial infarction(From the index dobutamine stress echocardiography date until fatal myocardial infarction (MI as cause of death), or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).)
- non-fatal myocardial infarction(From the index dobutamine stress echocardiography date until first non-fatal myocardial infarction, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).)
- stroke(From the index dobutamine stress echocardiography date until first stroke, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).)
- planned coronary revascularisation(From the index dobutamine stress echocardiography date until first planned coronary revascularisation, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).)
- unplanned coronary revascularisation(From the index dobutamine stress echocardiography date until first unplanned coronary revascularisation, or censoring at last available follow-up; assessed for up to 15 years (follow-up duration varies by participant).)