跳至主要内容
临床试验/NCT04738071
NCT04738071进行中(未招募)不适用

International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 3,730 人开始时间: 2019年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,730
试验地点
1
主要终点
Recurrent stroke

研究概览

简要总结

Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally.

The IMPROVE (International Multicenter Patent foRamen OVale & strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries.

The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Recurrent stroke

时间窗: Duration of follow-up (minimum of 3 months)

Recurrent hemorrhagic or ischemic stroke

次要结局

  • Incident atrial fibrillation(Duration of follow-up (minimum of 3 months))
  • Proportion of patients undergoing PFO closure(Within 12 months of the index diagnosis of PFO after the stroke or transient ischemic attack)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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