PATENT FORAMEN OVALE IN CRYPTOGENIC STROKE

隐源性中风中的卵圆孔未闭

• 批准号: 2270785
• 负责人: Shunichi Homma
• 金额: $ 41.08万
• 依托单位: COLUMBIA UNIV NEW YORK MORNINGSIDE
• 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 1998-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2270785
• 关键词: aspirin; cardiovascular disorder chemotherapy; cardiovascular disorder epidemiology; clinical trials; congenital heart septum defect; disease /disorder proneness /risk; echocardiography; human subject; human therapy evaluation; medical complication; relapse /recurrence; stroke; thromboembolism; warfarin

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.

40%的急性卵圆孔未闭（PFO）患者 缺血性卒中，其中卒中病因不明（隐源性 中风患者）。 新发隐源性卒中患者的发病率 据估计，PFO每年至少有48，000起。 许多人接受治疗， 华法林或阿司匹林 然而，中风复发或全身性中风的风险 药物治疗的隐源性卒中伴PFO患者的栓塞 不明 PFO闭合的一个可用选项，可以是 或手术存在，对这些方式的兴趣很高， 经验证的功效。 如果用于所有PFO的隐源性卒中患者， 潜在的国家成本将是巨大的。 在此之前， 程序可以考虑使用，有明确的需要确定 在医学上， 治疗的病人。 这样的审判将是极其昂贵的。 了一种解决方案 制定一项使用现有中风试验结构的研究。 Warranty抗血小板复发性卒中研究（WARSS）是一项NINDS- 受资助的多中心试验，以评估华法林与 阿司匹林在减少卒中复发或全身栓塞后 初始中风。 在WARSS中，来自30个中心的1,920名患者被随机分组， 双盲分配至华法林或阿司匹林组，并至少随访 2年。 然而，WARSS没有关于PFO识别的规定。 因此，本研究在此提出PFO在隐源性脑卒中中的研究 （PICSS），将使用WARSS结构识别隐源性卒中 然后接受经食管超声心动图检查PFO的患者 特征化 将按照WARSS对患者进行随机化和随访 议定书 30个WARSS中心中的27个将参加。 预计 入组PICSS的患者为474例隐源性卒中患者。 的假设 PFO是卒中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 这使得两年中风复发率或全身性中风的发生率 栓塞 由于患者随机接受华法林或阿司匹林治疗， 每种药物的卒中复发率或全身栓塞率可能 比较了 经食管超声心动图可以评估PFO 尺寸和检测其他潜在的心源性栓塞。 因此，我们认为， 药物治疗隐源性卒中自然史的初步数据 具有这些变量的患者也将可用。 此外，还 PFO隐源性卒中患者亚组， 复发或全身栓塞率特别高， 鉴定 这一群体可以作为今后的目标群体。 涉及其他治疗方式（如经皮闭合）的试验。