PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE

卵圆孔未闭(PFO)见于40%的急性胰腺炎患者。 卒中病因不明的缺血性卒中(病因不明 中风患者)。新的隐源性卒中患者的发病率 据估计，PFO每年至少有48,000人。许多人都接受了 华法林或阿司匹林。然而，中风复发或全身性中风的风险 经内科治疗的不明原因卒中合并PFO患者的栓塞术 是未知的。一种可行的PFO关闭选择，无论是经皮 或以手术方式存在，对这些方式的兴趣很高 已被证实的疗效。如果用于所有患有PFO的隐源性中风患者， 潜在的国家成本将是巨大的。因此，在这些之前， 程序是否可以考虑使用，显然有必要确定 医学上卒中复发或全身性栓塞率 治疗过的病人。这样的审判将耗资巨大。一个解决方案是 制定一项使用现有中风试验结构的研究。 华法林抗血小板复发性卒中研究(WARSS)是一项NINDS- 资助的多中心试验，以评估华法林与 阿司匹林减少卒中复发或术后全身栓塞 初始划水。在WARSS中，来自30个中心的1920名患者是随机的， 双盲分配给华法林或阿司匹林，并遵循最低限度 两年的时间。然而，WARSS没有关于确定PFO的规定。 因此，本研究提出，PFO在隐源性卒中中的研究 (PICSS)，将使用WARSS结构来识别隐源性中风 随后将接受经食道超声心动图检查的患者 人物刻画。患者将被随机分组，并根据WARSS进行跟踪 协议。30个WARSS中心中的27个将参加。预期 PICSS的登记人数为474名不明原因的中风患者。假说 测试结果是：PFO是中风复发的重要危险因素 内科治疗的隐源性卒中患者的全身栓塞术 使中风复发或全身性中风的两年复发率翻一番 栓塞术。由于患者随机服用华法林或阿司匹林， 每种药物的中风复发率或系统性栓塞率可能是 比较一下。经食道超声心动图可评估PFO 其他潜在心源性栓塞源的大小和检测。因此， 关于药物治疗的隐源性中风自然病史的试点数据 具有这些变量的患者也将可用。此外，一个 不明原因的卒中患者亚群中有PFO的患者 复发或全身栓塞率特别高的可能是 已确认身份。这一群体可以作为未来的目标群体 涉及其他治疗方式的试验，如经皮闭合。

Patent foramen ovale (PFO) is found in 40% of patients with acute ischemic stroke in whom the etiology of stroke is unclear (cryptogenic stroke patients). The incidence of new cryptogenic stroke patients with PFO is estimated to be at least 48,000 annually. Many are treated with warfarin or aspirin. However the risk of stroke recurrence or systemic embolization in medically treated cryptogenic stroke patients with PFO is unknown. An available option of PFO closure, either percutaneously or surgically exists and the interest in these modalities is high with proven efficacy. If used for all cryptogenic stroke patients with PFO, the potential national cost will be enormous. Therefore, before these procedures can be considered for use, there is a clear need to determine the rate of stroke recurrence or systemic embolization in medically treated patients. Such a trial will be extremely costly. A solution is to formulate a study that uses the structure of an existing stroke trial. The Warfarin Antiplatelet Recurrent Stroke Study (WARSS) is an NINDS- funded multi-center trial to assess the efficacy of warfarin versus aspirin in reducing stroke recurrence or systemic embolization after an initial stroke. In WARSS, 1,920 patients from 30 centers are randomly, double-blindly assigned to warfarin or aspirin and followed for a minimum of two-years. However, WARSS has no provision for PFO identification. Therefore, the study proposed here, PFO in Cryptogenic Stroke Study (PICSS), will use the WARSS structure in identifying cryptogenic stroke patients who will then undergo transesophageal echocardiography for PFO characterization. Patients will be randomized and followed per WARSS protocol. Twenty-seven of 30 WARSS centers will participate. Expected enrollment in PICSS is 474 cryptogenic stroke patients. The hypothesis tested is: PFO is an important risk factor for stroke recurrence or systemic embolization in medically-treated cryptogenic stroke patients which doubles the two-year rate of stroke recurrence or systemic embolization. Since patients are randomized to warfarin or aspirin the rate of stroke recurrence or systemic embolization on each agent may be compared. Transesophageal echocardiography allows for assessment of PFO size and detection of other potential cardioembolic sources. Therefore, pilot data on the natural history of medically treated cryptogenic stroke patients with these variables will also be available. Additionally, a subset of cryptogenic stroke patients with PFO in whom the stroke recurrence or systemic embolization rate is particularly high may be identified. This group could then serve as the target group for future trials involving other treatment modalities such as percutaneous closure.