International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
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
- 2
- 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
- 否
入选标准
- •(all of the following criteria should be fulfilled)
- •Age ≥18 years
- •Ischemic stroke or TIA within 5 years and 1 year before inclusion in the registry. Patients with cerebrovascular events occurred within one year before the inclusion in the registry should be part of the prospective cohort.
- •Ischemic stroke is defined as:
- •focal neurological deficit of central origin lasting ≥24 hours -except for death within 24hrs- with or without imaging confirmation of cerebral infarction; or
- •focal neurological deficit of central origin lasting <24 hours with corresponding imaging evidence of cerebral infarction; or
- •focal neurological deficit of central origin lasting <24 hours in patients receiving IV thrombolysis or endovascular thrombectomy with or without imaging confirmation of cerebral infarction; or
- •non-focal encephalopathy lasting more than 24 hours -except for death within 24hrs- with imaging evidence of cerebral infarction; or
- •acute and permanent retinal ischemia of arterial origin.
- •TIA is defined as:
- •focal neurological deficit of central origin lasting <24 hours without corresponding imaging evidence of cerebral infarction in patients not receiving IV thrombolysis or endovascular thrombectomy.
- •Confirmed patent foramen ovale.
排除标准
- •Exclusion Criteria
- •Age <18 years
- •Venous stroke
- •Stroke mimics
- •Patients with incomplete data at 12 months after the index ischemic stroke or TIA.
研究组 & 干预措施
Sex
Female and male patients
干预措施: PFO closure (Device)
Age >60 years of age
Patients younger or oder than 6o years of age
干预措施: PFO closure (Device)
World region
Patients from different world regions: North America, Europe, Asia, Latin America
干预措施: PFO closure (Device)
Stroke vs. TIA
Index event: stroke vs. TIA
干预措施: PFO closure (Device)
Neurocardiology Teams
Patients assessed by a neurocardiology team
干预措施: PFO closure (Device)
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
Luciano A. Sposato
Neurologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's