Development and Validation of a Risk Prediction Model for Ischemic Stroke in Acute Myocardial Infarction Without Comorbid Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- calibration
研究概览
简要总结
Study Goal:
This observational study aims to develop a tool to predict the risk of ischemic stroke(stroke caused by a blood clot) in people who survive a heart attack and do not have irregular heartbeats (atrial fibrillation) .
Key Questions:
Can we create an accurate tool using existing hospital records to identify which heart attack survivors without irregular heartbeats have the highest risk of stroke while still in the hospital? Can this tool reliably predict stroke risk at 3 months and 1 year after leaving the hospital?
About Participation:
This study will only use information from past patient medical records. If you had a heart attack and were treated at our hospital between January 1, 2014, and December 31, 2023 , and you did not have irregular heartbeats (atrial fibrillation), your anonymous health information might be included in this analysis.
No new patients are being recruited. This study analyzes existing information only.
No one will be asked to do anything new. We will not contact patients directly.
What Information Will Be Used?
Researchers will securely review past hospital records to look at information doctors usually collect during heart attack care, such as:
Your age and medical history (like previous strokes, diabetes, high blood pressure, kidney problems).
Test results (like heart pumping strength). Treatment details after your heart attack. Information on whether you had a stroke later. All personal details (like name, ID number) will be permanently removed to protect privacy.
Why This Matters:
People who survive a heart attack have a higher risk of stroke later, even without the common irregular heartbeat condition. A stroke can be life-threatening or seriously impact quality of life. This tool aims to help doctors in the future better understand a patient's individual stroke risk after a heart attack, so preventative steps can be discussed if needed.
Ethics & Safety:
Approved: This study has been reviewed and approved by our hospital's Ethics Committee to ensure it is safe and ethical.
Privacy Guaranteed: Your personal identity is protected. All data is stored securely on the hospital's protected network with strict access controls. No personal information leaves the hospital.
Researcher Note:
This tool is currently for research purposes only. It will not be used for your medical care right now.
If doctors want to use this tool in future clinical practice, a new study directly involving patients with their informed consent would be required.
详细描述
Title: Development and Validation of a Risk Prediction Model for Ischemic Stroke in Patients with Acute Myocardial Infarction without Atrial Fibrillation
Background:
Patients with acute myocardial infarction (AMI) who do not have atrial fibrillation (AF) still exhibit a significantly higher risk of ischemic stroke compared to the general population. A multicenter retrospective study by Ferreira et al. found that among patients with reduced left ventricular ejection fraction (LVEF ≤ 35%), the incidence of stroke was 5.97% in those with AF and 2.9% in those without AF over a median follow-up of 1.9 years. However, this study had important limitations: the population was restricted to patients with LVEF ≤ 35%, limiting generalizability; the endpoint was not clearly differentiated between ischemic stroke and intracerebral hemorrhage (although the latter accounted for less than 10%); and the risk of stroke in non-AF patients was underestimated at 1.5% annually, which is significantly higher than in healthy individuals. Ischemic stroke can severely worsen the prognosis of AMI patients. Evidence from clinical studies shows that the in-hospital mortality rate among patients with concomitant stroke is as high as 46.2%, compared to 6.3% in those without stroke, with a hazard ratio of 7.3. Even if stroke does not lead to death, it significantly impairs quality of life and increases public health expenditures.
The pathophysiology of ischemic stroke in non-AF AMI patients is complex and involves four major pathways:
Cardiogenic embolism: Detachment of left ventricular mural thrombi or spontaneous echo contrast (SEC) in the left atrium; Arterio-arterial embolism: Thrombosis resulting from rupture of atherosclerotic plaques in cerebral arteries; Paradoxical embolism: Deep vein thrombosis from the lower extremities passing through a patent foramen ovale; Hypercoagulable state: Endothelial dysfunction driven by systemic inflammatory responses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •myocardial infarction without atrial fibrillation
排除标准
- •Thrombophilia
- •Paradoxical Embolism through a Patent Foramen Ovale (PFO)
- •Iatrogenic embolism
- •Coronary slow-flow phenomenon
- •Coronary vasospasm
- •Dissection,
结局指标
主要结局
calibration
时间窗: 3 months, 5 years
Calibrationevaluates how closely predicted probabilities match actual observed outcomes in a prediction model. It measures whether a model's confidence in its predictions reflects reality.
AUC
时间窗: 3 months, 5 years
A standard metric to evaluate the performance of classification models.
次要结局
未报告次要终点