Clinical trial NCT06983795: Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study
Official title: Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Stroke
Patent Foramen Ovale
Keywords: Patent Foramen Ovale
Ischemic Stroke
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke or TIA and PFO identified would be screened for inclusion into the PACIFIC-PFO registry. Consecutive patients should be identified for inclusion by the local research team in each participating centers. Reason for exclusion after screening should be clearly stated and documented on a Screening and Enrollment Log, in order to minimize bias.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

1. Subject has experienced acute ischemic stroke or transient ischemic attack
2. 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
3. Age ≥18 years

Exclusion Criteria

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

Primary outcomes:
measure: Recurrent ischemic stroke or transient ischemic attack event within 1 year
timeFrame: Within 1 year
Secondary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 90 days
measure: Short term and long term neurological and cardiovascular outcomes
timeFrame: 90 days, 1 year, >1 year
Other outcomes:
measure: To validate PFO risk stratification scores in an Asia-Pacific cohort - RoPE score
timeFrame: 5 years
measure: To validate PFO risk stratification scores in an Asia-Pacific cohort - PASCAL score
timeFrame: 5 years
measure: To validate PFO risk stratification scores in an Asia-Pacific cohort - Spencer Grading
timeFrame: 5 years
measure: To evaluate the impact of access to PFO closure and availability of heart-brain teams on patient outcomes
timeFrame: 5 years
measure: To compare our regional data with other real-world registries or clinical trial data
timeFrame: 5 years
measure: Other objectives
timeFrame: 5 years
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
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citation: Overell JR, Bone I, Lees KR. Interatrial septal abnormalities and stroke: a meta-analysis of case-control studies. Neurology. 2000 Oct 24;55(8):1172-9. doi: 10.1212/wnl.55.8.1172.
citation: Koutroulou I, Tsivgoulis G, Tsalikakis D, Karacostas D, Grigoriadis N, Karapanayiotides T. Epidemiology of Patent Foramen Ovale in General Population and in Stroke Patients: A Narrative Review. Front Neurol. 2020 Apr 28;11:281. doi: 10.3389/fneur.2020.00281. eCollection 2020.