PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE

隐源性中风中的卵圆孔未闭

• 批准号: 2858157
• 负责人: Shunichi Homma
• 金额: $ 19.25万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-09-30 至 2000-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2858157
• 关键词: aspirin; cardiovascular disorder chemotherapy; cardiovascular disorder epidemiology; clinical research; clinical trials; congenital heart septum defect; disease /disorder prevention /control; disease /disorder proneness /risk; echocardiography; human subject; human therapy evaluation; longitudinal human study; medical complication; outcomes research; relapse /recurrence; statistics /biometry; stroke; thromboembolism; ultrasound blood flow measurement; warfarin

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.

40% 的隐源性患者存在卵圆孔未闭 (PFO) 中风。许多人接受华法林或阿司匹林治疗。然而，风险 药物治疗中风后全身栓塞的中风复发 PFO 患者的情况尚不清楚。 PFO 可选择经皮或 存在手术闭合并且对这些方式的兴趣很高 未经证实的功效。如果 这些方法适用于所有患有 PFO 的中风患者。因此，之前 这些程序可以考虑常规使用，有明确的需要 确定中风复发或全身栓塞的发生率 患有 PFO 的中风患者接受药物治疗。这样的审判将是极其 昂贵。一个解决方案是使用现有的中风试验的结构， 华法林阿司匹林复发性中风研究（WARSS）。这是 NINDS 资助的 评估华法林与阿司匹林疗效的多中心试验 减少初次中风后的死亡或中风。系统性数据 栓塞也可用 在 WARSS 中，来自 50 个中心的 1,920 名患者 随机、双盲分配至华法林或阿司匹林并进行随访 至少两年。然而，WARSS没有规定没有 PFO 识别的规定。因此，本研究提出 隐源性中风研究 (PICSS) 中的延续 PFO，使用 WARSS 结构 确定将被邀请的隐源性中风患者 接受经食管超声心动图 (TE) 以了解 PFO 特征。 任何出于临床目的接受 TE 的 WARSS 患者也 已注册。检验的假设是：PFO 是一个重要的危险因素 经药物治疗的中风复发或全身栓塞 两年中风复发率或全身性中风复发率加倍的患者 栓塞。目前有 43 个中心参与，截至 2097 年 1 月 31 日，已有 476 个中心参与 1,717 名 WARSS 患者入组。由于患者被随机分配到 华法林或阿司匹林，中风复发率或全身性 可以比较每种药物的栓塞情况。经超声心动图允许 用于评估其他潜在的心脏栓塞源（主动脉弓 斑块、自发回声对比、房间隔动脉瘤和瓣膜 股）。因此，有关医学自然史的试点数据 接受过这些变量治疗的中风患者也将变得可用。 为了最大限度地提高 PICSS 的入学率，需要持续提供资金， 收集并分析 TE 磁带，并按顺序执行必要的分析 以实现既定目标。