PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE

隐源性中风中的卵圆孔未闭

• 批准号: 6139506
• 负责人: Shunichi Homma
• 金额: $ 19.45万
• 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 2001-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6139506
• 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%的隐源性患者可发现卵圆孔未闭。 卒中。许多人接受华法林或阿司匹林治疗。然而，风险是 经内科治疗的卒中患者全身栓塞术后的卒中复发 患有PFO的患者尚不清楚。经皮穿刺或经皮肺泡灌洗的选择 外科手术是存在的，人们对这些方式的兴趣很高。 没有经过验证的疗效。潜在的国家成本将是巨大的，如果 这些方法适用于所有患有PFO的中风患者。因此，之前 这些程序可以考虑作为常规使用，有明显的需要 以确定卒中复发或全身栓塞率 对患有PFO的中风患者进行内科治疗。这样的审判将是极其艰难的 代价不菲。一种解决方案是使用现有中风试验的结构， 华法林、阿司匹林复发性卒中研究(WARSS)。这是NINDS资助的 华法林与阿司匹林对照的多中心临床试验 减少初次中风后的死亡或中风。关于系统性的数据 WARSS也提供栓塞术，来自50个中心的1,920名患者 被随机、双盲分配给华法林或阿司匹林，然后 至少两年。然而，WARSS没有规定没有 关于确定PFO的规定。因此，这项研究建议 隐源性卒中研究中的延续PFO(PICSS)，使用WARSS结构 在识别将被征集到的隐源性中风患者 接受经食道超声心动图(TE)检查以确定PFO的特征。 任何WARSS患者为了临床目的而接受TE也是 已注册。检验的假设是：PFO是一个重要的风险因素 内科治疗的卒中复发或全身栓塞术 中风复发或全身性中风的两年复发率翻一番的患者 栓塞术。目前有43个中心参与，截至1997年1月31日，共有476个中心参与 1717名WARSS患者入选。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 可以比较每种药剂的栓塞率。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，关于医学自然历史的试点数据 具有这些变量的中风患者也将得到治疗。 要求继续提供资金，以便最大限度地扩大PICSS的登记人数， 收集和分析TE磁带，并按顺序执行必要的分析 以实现所设定的目标。

项目成果

Patent foramen ovale, cardiac valve thickening, and antiphospholipid antibodies as risk factors for subsequent vascular events: the PICSS-APASS study.

• DOI: 10.1161/strokeaha.108.539171
• 发表时间: 2009-07
• 期刊: Stroke
• 影响因子: 8.3
• 作者: Rajamani K;Chaturvedi S;Jin Z;Homma S;Brey RL;Tilley BC;Sacco RL;Thompson JL;Mohr JP;Levine SR;PICSS-APASS Investigators
• 通讯作者: PICSS-APASS Investigators