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

NCT06983795 | Not Yet Recruiting

• 1 other identifier: PACIFIC-PFO
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Patent Foramen Ovale

Keywords

Patent Foramen Ovale; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Recurrent ischemic stroke or transient ischemic attack event within 1 year

  Ischemic stroke is defined as: Acute focal neurological dysfunction caused by focal infarction at single or multiple sites of the brain or retina. Evidence of acute infarction may come either from A) Symptom duration lasting more than 24 hours B) Neuroimaging or other technique in the clinically relevant area of the brain TIA is defined as: A transient episode of focal neurological dysfunction caused by focal brain or retinal ischemia without acute infarction in the clinically relevant area of the brain or retina. Symptoms should resolve completely within 24 hours.

  Within 1 year

Secondary Outcomes (2)

• Modified Rankin Scale (mRS)

  90 days

• Short term and long term neurological and cardiovascular outcomes

  90 days, 1 year, >1 year

Other Outcomes (6)

• To validate PFO risk stratification scores in an Asia-Pacific cohort - RoPE score

  5 years

• To validate PFO risk stratification scores in an Asia-Pacific cohort - PASCAL score

  5 years

• To validate PFO risk stratification scores in an Asia-Pacific cohort - Spencer Grading

  5 years

Study Arms (1)

Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack.

The PACIFIC-PFO registry aims to include patients from Asia and Oceania. Academic, non-academic, urban and rural sites will be included. Principal investigators will be neurologists or cardiologists. A confirmed diagnosis of ischemic stroke or TIA is mandatory before enrolment. Information on the interventions performed and treatment instigated (e.g. PFO closure, medical therapy) will be collected.

Procedure: PFO closure using approved PFO closure devices, Surgical PFO closure; Drug: Medical management

Interventions

PFO closure using approved PFO closure devices, Surgical PFO closure PROCEDURE

PFO closure using approved PFO closure devices, Surgical PFO closure

Also known as: Amplatzer™ Septal Occluder, Amplatzer™ PFO Occluder, Amplatzer™ Cribriform (for a septum with more than one hole), Gore® Cardioform Septal Occluder, Gore® Cardioform ASD Occluder (for larger ASDs), STARFlex® Septal Closure System

Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack.

Medical management DRUG

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)

Also known as: Antiplatelet therapy e.g. aspirin, clopidogrel, ticagrelor, dipyridamole, cilostazol, or a combination of these medications, Anticoagulation e.g warfarin, direct oral anticoagulants

Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. JAMA. 2021 Dec 14;326(22):2277-2286. doi: 10.1001/jama.2021.20956.

  PMID: 34905030 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 11071496 BACKGROUND

• 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.

  PMID: 32411074 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Foramen Ovale, Patent

Interventions

Practice Management, Medical; Clopidogrel; Ticagrelor; Dipyridamole; Cilostazol; N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Pyrimidines; Tetrazoles; Azoles; Quinolines

Central Study Contacts

Benjamin Y Tan, MBBS

CONTACT

+65 6779 5555; benjamin_yq_tan@nuhs.edu.sg

Ching-Hui Sia, MBBS

CONTACT

+65 6779 5555; ching_hui_sia@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: May 21, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 21, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)