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

Not yet recruiting

• Conditions: Ischemic Stroke; Patent Foramen Ovale
• Interventions: Procedure: PFO closure using approved PFO closure devices, Surgical PFO closure; Drug: Medical management

• Registration Number: NCT06983795
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-07
• Primary Completion: 2027-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack.	Medical management	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.
Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack.	PFO closure using approved PFO closure devices, Surgical PFO closure	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.

Primary Outcome Measures

Name	Time	Method
Recurrent ischemic stroke or transient ischemic attack event within 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Short term and long term neurological and cardiovascular outcomes	90 days, 1 year, >1 year	1. Recurrent stroke or TIA; 2. Systemic embolism; 3. Acute myocardial infarction; 4. Cardiovascular mortality; 5. All-cause mortality; 6. Major and minor bleeding defined according to the ISTH criteria; 7. Intracranial hemorrhage
Modified Rankin Scale (mRS)	90 days	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore