PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE

卵圆孔未闭（PFO）见于40%的隐源性 中风许多人用华法林或阿司匹林治疗。然而，风险 药物治疗卒中后全身性栓塞的卒中复发 PFO患者不详。PFO的选择，经皮或 存在外科闭合，并且对这些方式的兴趣很高 没有经过验证的功效。潜在的国家成本将是巨大的， 这些方法用于所有患有PFO的中风患者。因此，在 这些程序可以考虑用于日常使用， 以确定中风复发率或全身栓塞， 接受药物治疗的PFO中风患者。这样的审判将是极其 很贵。一种解决方案是利用现有中风试验的结构， 阿司匹林复发性卒中研究（WARSS）。这是一个NINDS资助的 一项多中心试验，评估华法林与阿司匹林在 减少初次中风后的死亡或中风。系统数据 在WARSS中，来自50个中心的1，920名患者也可进行栓塞治疗 随机、双盲分配华法林或阿司匹林， 至少两年然而，WARSS没有规定， PFO识别规定。因此，研究建议， 隐源性卒中研究（PICSS）中的持续PFO，使用WARSS结构 在识别隐源性中风患者时， 接受经食管超声心动图（TE）进行PFO表征。 任何出于临床目的接受TE的WARSS患者也 注册了检验的假设是：PFO是一个重要的危险因素， 药物治疗卒中后卒中复发或全身栓塞 患者的两年卒中复发率或全身性卒中复发率 栓塞目前有43家中心参与，截至1997年1月31日， 1，717例WARSS患者入组。由于患者被随机分配至 华法林或阿司匹林，卒中复发率或全身 可以比较每种药剂上的栓塞。经胸超声心动图检查 用于评估其他潜在心源性栓塞源（主动脉弓 斑块、自发性回声对比、房间隔动脉瘤和瓣膜 股）。因此，关于医学自然史的试点数据 具有这些变量的治疗过的中风患者也将可用。 要求继续提供资金，以最大限度地提高PICSS的入学率， 收集和分析TE磁带，并进行必要的分析， 以实现既定目标。

Patent foramen ovale (PFO) is found in 40% of patients with cryptogenic stroke. Many are treated with warfarin or aspirin. However the risk of stroke recurrence of systemic embolization in medically treated stroke patients with PFO is unknown. Option of PFO either percutaneous or surgical closure exists and the interest in these modalities is high without proven efficacy. The potential national cost will be enormous if these methods are used for all stroke patients with PFO. Therefore, before these procedures can be considered for routine use, there is a clear need to determine the rate of stroke recurrence or systemic embolization in medically treated stroke patients with PFO. Such a trial will be extremely costly. A solution is to use the structure of existing stroke trial, Warfarin Aspirin Recurrent Stroke Study (WARSS). This is an NINDS-funded multi-center trial to assess the efficacy of warfarin versus aspirin in reducing death or stroke after an initial stroke. Data on systemic embolization is also available In WARSS, 1,920 patients from 50 centers are randomly, double-blindly assigned to warfarin or aspirin and followed for a minimum of two-years. However, WARSS has no provision has no provision for PFO identification. Therefore, the study proposed for continuation PFO in Cryptogenic Stroke Study (PICSS), used WARSS structure in identifying cryptogenic stroke patients who will be solicited to undergo transesophageal echocardiography (TE) for PFO characterization. Any WARSS patients that undergo TE for clinical purposes are also enrolled. The hypothesis tested is: PFO is an important risk factor for stroke recurrence or systemic embolization in medically treated stroke patients which double the two-year rate of stroke recurrence or systemic embolization. Currently 43 centers participate and as of 01/31/97, 476 of 1,717 WARSS patients are enrolled. Since patients are randomized to warfarin or aspirin, the rate of stroke recurrence or systemic embolization on each agent may be compared. Trans echocardiography allows for assessment of other potential cardioembolic source (aortic arch plaques, spontaneous echo contrast, atrial septal aneurysm and valve strands). Therefore, pilot data on the natural history of medically treated stroke patients with these variables will also become available. Continued funding is requested in order to maximize PICSS enrollment, collect and analyze TE tapes, and to perform necessary analyses in order to achieve the aims set forth.