Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study (PACIFIC-PFO)

National University Health System (NUHS)

Status: Not yet enrolling

Conditions: Ischemic Stroke; Patent Foramen Ovale

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

Study type: Observational

Funder types: Other

Identifiers

NCT06983795

PACIFIC-PFO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,000 participants in 1 patient group

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

Description:

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.

Treatment:

Drug: Medical management

Procedure: PFO closure using approved PFO closure devices, Surgical PFO closure