Health TrialsbyHealthPanel

Prospective Registry of Elderly ESUS With PFO

ConditionEmbolic Stroke of Undetermined Source
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorAsan Medical Center

About this trial

Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 60 years-old

Patients diagnosed as ESUS within 180 days from onset

PFO found from TTE or TEE, which attributed to the ischemic stroke

Patients or their legal representative agreed to participate

Disqualifiers

Patients with transient ischemic attack

Patients with ischemic stroke at the vascular territory with significant stenosis

Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography

Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)

Trial population

Elderly ESUS patients

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • PFO closure

    Procedure/Surgery

    PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Experimental: intervention group1 intervention
Group B: Active comparator: control group0 interventions

Trial outcomes

Primary outcomes

1

ischemic stroke recurrence

Time to occurrence of ischemic stroke after registration

Time frame
at least 1 year

Secondary outcomes

1

MACE

Time to major cardiovascular event after registration

Time frame
at least 1 year
2

Hemorrhagic stroke

Time to hemorrhagic stroke after registration

Time frame
at least 1 year
3

Vascular death

Time to vascular death after registration

Time frame
at least 1 year
4

Myocardial infarction

Time to myocardial infarction

Time frame
at least 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

National Evidence-Based Healthcare Collaborating Agency

Collaborator

Source ClinicalTrials.gov
Apply now