Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1500 participants
OBSERVATIONAL
2008-09-08
2021-12-31
Brief Summary
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Detailed Description
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The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Even if RCTs are completed successfully, statistical differences may remain undetected with the planned sample sizes. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates.
Objective
1\) To compare the risk of recurrent stroke and TIA in patients aged ≤ 55 years with PFO and otherwise unexplained stroke who undergo PDC or receive ATT only; 2) To assess the etiological role of PFO for stroke/TIA in patients aged \> 55 years; 3) To assess the risk of recurrent stroke/TIA in "high-risk" PFO patients (i.e. those with spontaneous (at rest) or large RLS, coinciding ASA, or multiple previous cerebrovascular events).
Methods
Multicenter prospective non-randomized study with scheduled 3-years follow-up of patients with PFO and ischemic stroke or TIA. Participating centers: Swiss University Hospitals of Basel, Bern, Geneva, Lausanne and Zurich, the Cantonal Hospital of Aarau, the Triemli Hospital, the Alfried-Krupp Krankenhaus of Essen, the University Hospital of Essen, the Klinikum Worms gGmbH, Tufts Medical Center, Baystate Medical Center, the East Medical Center Tyler, and the University Hospital of Leuven.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Patients who receive antithrombotic treatment only
Antithrombotic treatment
antiplatelets, anticoagulants
2
Patients who undergo percutaneous device closure
percutaneous device closure of PFO
umbrella device for PFO closure
Interventions
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Antithrombotic treatment
antiplatelets, anticoagulants
percutaneous device closure of PFO
umbrella device for PFO closure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of PFO established by transesophageal echocardiography (TEE)
* Ischemic stroke or transient ischemic attack within the previous 6 months
Exclusion Criteria
* Comorbid condition that would interfere with the study
* Pregnancy
* History of intracranial bleeding, confirmed arterio-venous malformation, aneurysm or uncontrolled coagulopathy
* Contraindications for TEE, echocardiographic or iodine contrast media
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
University of Lausanne Hospitals
OTHER
University Hospital, Geneva
OTHER
University Hospital, Zürich
OTHER
Triemli Hospital
OTHER
Cantonal Hospital of Aarau, Switzerland
OTHER
Alfried-Krupp Krankenhaus of Essen, Germany
UNKNOWN
University Hospital, Essen
OTHER
Klinikum Worms
OTHER
Tufts Medical Center
OTHER
Baystate Medical Center
OTHER
East Medical Center Tyler, Texas
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Ammerland Klinik GmbH, Westerstede, Germany
UNKNOWN
University Hospital, Ghent
OTHER
Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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University of Bern and Triemli Hospital Zurich
Principal Investigators
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Krassen Nedeltchev, MD
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Aarau
Marie-Luise Mono, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Neurology, Bern University Hospital, Bern
Marcel Arnold, MD
Role: STUDY_DIRECTOR
University of Bern, Inselspital
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
East Medical Center
Tyler, Texas, United States
University Hospital Gent
Ghent, , Belgium
Leuven University Hospital
Leuven, , Belgium
Alfried Krupp Hospital
Essen, , Germany
Essen University Hospital
Essen, , Germany
Ammerland Klinik GmbH
Westerstede, , Germany
Klinikum Worms gGmbH
Worms, , Germany
Arcispedale Santa Maria Nuova, Department of Neurology, ASMN IRCCS
Reggio Emilia, , Italy
University Hospital Doctor Josep Trueta
Girona, , Spain
Cantonal Hospital of Aarau
Aarau, , Switzerland
Basel University Hospital
Basel, , Switzerland
Department of Neurology, Bern University Hospital, Bern
Bern, , Switzerland
Geneva University Hospital
Geneva, , Switzerland
Lausanne University Hospital
Lausanne, , Switzerland
Zürich Triemli Hospital
Zurich, , Switzerland
Zürich University Hospital
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Dimitri Hemelsoet, MD
Role: primary
Andreas Müller-Eichelberg, MD
Role: primary
Joaquín Serena, MD
Role: primary
Marie-Luise Mono
Role: primary
Other Identifiers
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117/08
Identifier Type: -
Identifier Source: org_study_id