相关实验视频
Updated: Jun 27, 2025

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
在老年中风患者中专利的卵巢孔关闭:为可行性试验的患者选择
Andy Y Wang1, Peter M Rothwell1, Jason Nelson1
1From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London, United Kingdom; Comprehensive Stroke Center and Department of Neurology (J.L.S.), David Geffen School of Medicine, University of California, Los Angeles; Comprehensive Stroke Center (S.E.K.), Department of Neurology, University of Pennsylvania Medical Center, Philadelphia; Division of Cardiology (J.C.), Department of Medicine, University of Colorado Denver, Aurora; Université Paris Cité (J.-L.M.), Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM U1266; GHU-Paris Psychiatrie et Neurosciences (J.-L.M.), Hôpital Sainte Anne; Département de Physiologie (G.D.), Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Université Paris-Est Créteil (UPEC); Centre d'Investigations Cliniques (G.C.), Unité de Recherche Clinique, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, France; Department of Neurology (A.J.F.), Case Western Reserve University, Cleveland, OH; Division of Cardiovascular Medicine (H.C.H., B.L.), Perelman School of Medicine at the University of Pennsylvania, Philadelphia; Department of Population Health (P.J.), University of Oxford, United Kingdom; Department of Neurology (J.S.K.), Gangneung Asan Hospital, University of Ulsan College of Medicine; Department of Cardiology (P.H.L.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; Department of Neurology (H.P.M.), Bern University Hospital; Medical Faculty (B.M.), University of Bern, Switzerland; Cardiology Department (M.R.), Weill Cornell Medical Center, Cornell, NY; Division of Cardiology (R.W.S.), Department of Medicine, UTHealth/McGovern Medical School and The Memorial Hermann Heart and Vascular Institute, Houston, TX; Department of Cardiology (L.S.), Rigshospitalet, Copenhagen University Hospital, Denmark; Division of Cardiology (J.-K.S.), Asan Medical Center Heart Institute, University of Ulsan College of Medicine, Seoul, South Korea; BHF Cardiovascular Epidemiology Unit (E.D.A.), Department of Public Health and Primary Care, University of Cambridge; Victor Phillip Dahdaleh Heart and Lung Research Institute (E.D.A.), BHF Centre of Research Excellence, School of Clinical Medicine, Addenbrooke's Hospital; NIHR Blood and Transplant Research Unit in Donor Health and Behaviour (E.D.A.), all University of Cambridge; Health Data Research UK Cambridge (E.D.A.), Wellcome Genome Campus and University of Cambridge, Hinxton; University of Cambridge (E.D.A.), United Kingdom; Health Data Science Centre (E.D.A.), Human Technopole, Milan, Italy; Department of Medicine (M.D., S.H.), Columbia University, College of Physicians and Surgeons, New York, NY; Department of Neurology (M.S.V.E.), Vagelos College of Physicians and Surgeons, and Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY; Division of Neurology-Stroke Program (C.J.), Department of Medicine, University Health Network, Toronto Western Hospital, Ontario, Canada; Stroke Center (P.M.), Neurology Service, Lausanne University Hospital; Department of Neurology (M.-L.M., K.N.), University of Bern; Department of Neurology (M.-L.M.), Stadtspital Zürich; Department of Neurology and Stroke Centre (K.N.), Cantonal Hospital Aarau, Switzerland; Sapienza University of Rome (F.P.), Italy; Department of Neurology (J.S.), Hospital Universitari de Girona Dr Josep Trueta - IDIBGI, Spain; Department of Neurology and Stroke Center (C.W.), University Duisburg-Essen, Germany; Department of Public Health (D.K.), Erasmus University Medical Center, Rotterdam, the Netherlands; and Department of Neurology (D.E.T.), Tufts Medical Center/Tufts University School of Medicine, Boston, MA.
专利卵孔 (PFO) 关闭可能有利于加密性中风的老年人,特别是那些具有高风险特征的人. 通过选择性地招募这些患者来确定PFO关闭的有效性,未来的临床试验是可行的.
科学领域:
- 心脏病学 心脏病学
- 神经学 神经学
- 临床试验 临床试验
背景情况:
- 专利卵孔 (PFO) 关闭试验主要包括60岁以下的患者.
- 在患有密码性中风的老年人中,PFO关闭的益处仍然不清楚.
- 这项研究旨在估计PFO关闭对老年患者的影响,以告知未来的研究.
研究的目的:
- 为了估计PFO关闭在老年患者 (60岁以上) 密码性中风的有效性.
- 确定在这个人群中进行随机对照试验 (RCT) 所需的样本大小.
- 确定可能从PFO关闭中受益最多的患者子组.
主要方法:
- 来自观察性研究 (RoPE-Ox) 和RCT (SCOPE联盟) 的综合数据.
- 使用观察数据计算60岁以上患者中风复发风险.
- 在RCT数据上开发了考克斯回归模型,以估计PFO关闭与医疗治疗的中风风险降低.
主要成果:
- 5年中风复发风险总体为13.7%,高风险PFO患者的风险为14.9%.
- 关闭PFO预计总体相对风险降低12.9%,高风险患者降低48.8%.
- 一个RCT将需要471-630名具有高风险PFO特征的患者,以达到80-90%的功率.
结论:
- 关闭PFO显示在具有高风险PFO特征的老年人中具有潜在的益处.
- 专注于这个子组的临床试验是可行的.
- 鉴于年龄增长的预期寿命,研究老年人PFO关闭是至关重要的.

