Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study

Обзор

A registry of patients from the Asia-Pacific region with PFO and ischemic stroke, designed to study the characteristics, investigations, treatment and outcomes using real-world data.

Подробное описание

This is an observational, multi-center, non-randomized real-world registry including ischemic stroke and/or transient ischemic attack patients with PFO in the Asia Pacific region. The primary objective of this registry is to assess the clinical characteristics and outcomes of patients with PFO and stroke or TIA using real-world data in the Asia-Pacific region, including patients who underwent PFO closure versus medical management only.

Patients who had ischemic stroke or TIA within 5 years of inclusion into the registry, with follow up data of at least 1 year. Patients with AIS or TIA within one year of inclusion into the registry will be part of the prospective cohort. The total duration of the registry will be approximately 3 years.

Вмешательства

• Процедура PFO closure using approved PFO closure devices, Surgical PFO closure
  PFO closure using approved PFO closure devices, Surgical PFO closure
• Препарат Medical management
  Antiplatelet therapy * ASA, also called acetylsalicylic acid (Aspirin, Asaphen, Entrophen, Novasen) * clopidogrel (Plavix) * ticagrelor (Brilinta) * dipyridamole (Persantine) * cilostazol Anticoagulation therapy * apixaban (Eliquis) * dabigatran (Pradaxa) * edoxaban (Lixiana) * rivaroxaban (Xarelto) * warfarin (Coumadin)

Первичные конечные точки

• Recurrent ischemic stroke or transient ischemic attack event within 1 year [Срок оценки: Within 1 year]

Вторичные конечные точки (2)

• Modified Rankin Scale (mRS) [Срок оценки: 90 days]
• Short term and long term neurological and cardiovascular outcomes [Срок оценки: 90 days, 1 year, >1 year]

Критерии участия

Критерии включения

• Subject has experienced acute ischemic stroke or transient ischemic attack
• Subject is screened with presence of PFO (right-to-left shunt) on appropriate cardiac imaging (transthoracic echocardiography and/or transesophageal echocardiography) or transcranial Doppler bubble study
• Age ≥18 years

Критерии исключения

• Stroke mimics, haemorrhagic stroke or cerebral venous thrombosis
• Subjects with less than 3 months of follow up

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Сингапур · 1 центр

• National University Hospital — Singapore

Публикации

• Saver JL, Mattle HP, Thaler D. Patent Foramen Ovale Closure Versus Medical Therapy for Cryptogenic Ischemic Stroke: A Topical Review. Stroke. 2018 Jun;49(6):1541-1548. doi: 10.1161/STROKEAHA.117.018153. Epub 2018 May 14. No abstract available. PMID 29760277
• Kim JS, Thijs V, Yudi M, Toyoda K, Shiozawa M, Zening J, Clapp B, Albers B, Diener HC. Establishment of the Heart and Brain Team for Patent Foramen Ovale Closure in Stroke Patients: An Expert Opinion. J Stroke. 2022 Sep;24(3):345-351. doi: 10.5853/jos.2022.02103. Epub 2022 Sep 30. PMID 36221937
• Toh KZX, Koh MY, Ho JSY, Ong KHX, Lee YQ, Chen X, Fang JT, Chong EY, Lim ICZY, Teo YH, Teo YN, Chua CYK, Lim Y, Chan BPL, Sharma VK, Yeo LLL, Sia CH, Tan BYQ. Potential Embolic Sources in Embolic Stroke of Undetermined Source Patients with Patent Foramen Ovale. Cerebrovasc Dis. 2023;52(5):503-510. doi: 10.1159/000527791. Epub 2022 Dec 1. PMID 36455524
• Diener HC, Akagi T, Durongpisitkul K, Thomson VS, Prabhakar AT, Sharpe R, Albers B, Lewalter T, Oki K, Sharma VK. Closure of the patent foramen ovale in patients with embolic stroke of undetermined source: A clinical expert opinion and consensus statement for the Asian-Pacific region. Int J Stroke. 2020 Dec;15(9):937-944. doi: 10.1177/1747493020941658. Epub 2020 Jul 17. PMID 32677579
• Kent DM, Saver JL, Ruthazer R, Furlan AJ, Reisman M, Carroll JD, Smalling RW, Juni P, Mattle HP, Meier B, Thaler DE. Risk of Paradoxical Embolism (RoPE)-Estimated Attributable Fraction Correlates With the Benefit of Patent Foramen Ovale Closure: An Analysis of 3 Trials. Stroke. 2020 Oct;51(10):3119-3123. doi: 10.1161/STROKEAHA.120.029350. Epub 2020 Sep 14. PMID 32921262
• Kent DM, Saver JL, Kasner SE, Nelson J, Carroll JD, Chatellier G, Derumeaux G, Furlan AJ, Herrmann HC, Juni P, Kim JS, Koethe B, Lee PH, Lefebvre B, Mattle HP, Meier B, Reisman M, Smalling RW, Soendergaard L, Song JK, Mas JL, Thaler DE. Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke. PMID 34905030
• Kent DM, Ruthazer R, Weimar C, Mas JL, Serena J, Homma S, Di Angelantonio E, Di Tullio MR, Lutz JS, Elkind MS, Griffith J, Jaigobin C, Mattle HP, Michel P, Mono ML, Nedeltchev K, Papetti F, Thaler DE. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013 Aug 13;81(7):619-25. doi: 10.1212/WNL.0b013e3182a08d59. Epub 2013 Jul 17. PMID 23864310
• Turc G, Calvet D, Guerin P, Sroussi M, Chatellier G, Mas JL; CLOSE Investigators. Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta-Analysis, and New Insights From the CLOSE Study. J Am Heart Assoc. 2018 Jun 17;7(12):e008356. doi: 10.1161/JAHA.117.008356. PMID 29910193

Идентификаторы

NCT: NCT06983795 · PACIFIC-PFO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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