Ischemic Stroke, Patent Foramen Ovale
Conditions
Keywords
Patent Foramen Ovale, Ischemic Stroke
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.
Interventions
PROCEDUREPFO closure using approved PFO closure devices, Surgical PFO closure
PFO closure using approved PFO closure devices, Surgical PFO closure
DRUGMedical 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)
Sponsors
National University Hospital, Singapore
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the impact of access to PFO closure and availability of heart-brain teams on patient outcomes | 5 years | The outcomes of the patients will be compared between centres with PFO closures services and heart-brain teams with those without. Patients treated by a heart-brain multi-disciplinary team were compared to those who were not. |
| To validate PFO risk stratification scores in an Asia-Pacific cohort - RoPE score | 5 years | PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding. ROPE score The RoPE score ranges from 0 to 10, with scores of 0 to 3 indicating a negligible likelihood that the stroke is attributable to the PFO and a score of 10 indicating an approximately 90% probability that the stroke is attributable to the PFO. |
| Other objectives | 5 years | To identify other variables associated with PFO-related stroke specific to the Asian population, and to develop Asian-specific risk stratification methods which may have higher predictive values. Exploratory analysis of patients with PFO closure will be performed, for outcomes such as incidence of atrial fibrillation. |
| To compare our regional data with other real-world registries or clinical trial data | 5 years | To compare the patient characteristics, investigations, treatment and management in this regional registry with other published registries or clinical trials. |
| To validate PFO risk stratification scores in an Asia-Pacific cohort - PASCAL score | 5 years | PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding. PASCAL score PASCAL combines the RoPE score with the presence or absence of high-risk PFO features to determine the likelihood that the PFO was causally related to the index stroke |
| To validate PFO risk stratification scores in an Asia-Pacific cohort - Spencer Grading | 5 years | PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding. Spencer algorithm grading scale with transcranial Doppler bubble study methodology |
Countries
Singapore
Contacts
Primary ContactBenjamin Y Tan, MBBS
Backup ContactChing-Hui Sia, MBBS
Outcome results
None listed