Development of a Prognostic Tool for the Stratification of Cardiovascular Risk in Patients With Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- A well-validated prognostication tool for the stratification of the risk of major adverse cardiovascular events in patients with ischemic stroke regardless of the underlying etiology or the pathophysiologic mechanism of the index stroke
研究概览
简要总结
The availability of several high-cost strategies for the prevention of cardiovascular morbidity and mortality in patients with established cardiovascular disease highlights the necessity of reliable risk stratification of these patients. Several such prognostic models are available for patients with coronary artery disease; however, for patients with ischemic stroke, the available risk stratification schemes are very few and have several limitations.
This study aims to develop a prognostication tool to stratify the risk of cardiovascular outcomes in patients with ischemic stroke.
The development of a well-designed prognostication tool for the stratification of cardiovascular risk in patients with ischemic stroke may assist to the identification of the highest-risk patients and hence, provide useful information to clinicians and authoritative bodies when prioritizing high-cost strategies for secondary stroke prevention.
详细描述
Background and rationale Patients with established cardiovascular disease are at very high risk for recurrent cardiovascular events and mortality1. Nevertheless, within this very high risk group, there is significant variation of the underlying risk with some patients being at the extreme edge of the spectrum2,3.
The identification of these patients is of utmost importance as it may have implications for management strategies such as prioritization of high-cost strategies like PCSK9 inhibitors and aggressive treatment of modifiable risk factors like arterial hypertension and dyslipidemia. Refined risk stratification may also guide treatment decisions in situations where the balance between the expected benefit and the risk of serious adverse events is borderline like in patients with high bleeding risk who need aggressive antithrombotic treatment, or patients with intracranial bleeding and an indication for antithrombotic treatment4. In addition, it may allow identify those patients who may benefit more from an intensive follow-up schedule. Finally, improved risk stratification may have a positive impact on the motivation of the patient to adhere to secondary prevention strategies.
Identification of patients at greater risk of secondary vascular events after ischaemic stroke is challenging because stroke is an etiologically heterogeneous syndrome which may be caused by a diverse set of pathophysiologically discrete diseases like atrial fibrillation (AF), small vessel disease, atherosclerosis and others5.
The CHA2DS2VASc score has been shown to predict long-term stroke outcomes in patients with ischaemic stroke, both with and without AF6-8.
The Essen Stroke Risk score (ESRS) was derived from patients with ischaemic stroke in the CAPRIE trial and was shown to stratify the 1-year risk of stroke recurrence or major vascular events9.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 130 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with acute ischemic stroke registered in the Athens Stroke registry will be included in the analysis regardless of the underlying etiology or pathophysiologic mechanism
排除标准
- •Patients with intracranial haemorrhage or transient ischemic attack
结局指标
主要结局
A well-validated prognostication tool for the stratification of the risk of major adverse cardiovascular events in patients with ischemic stroke regardless of the underlying etiology or the pathophysiologic mechanism of the index stroke
时间窗: prognostication tool for major cardiovascular adverse events reported during the follow up period, up to 10 years
The primary outcome of the study is to built a prognostication tool, in order to predict which stroke patients are going to have the highest risk of secondary major cardiovascular events
次要结局
未报告次要终点
研究者
George Ntaios
Assistant Professor of Medicine
University of Thessaly
