pLatelEts And MigRaine iN patEnt foRamen Ovale
Condition: Platelet Aggregation, Spontaneous; Migraine With Aura; Patent Foramen Ovale
MeSH terms: Migraine Disorders; Migraine with Aura; Foramen Ovale, Patent
Study type: Interventional

Summary: 
      Migraine is a common, chronic neurovascular disorder characterized by attacks of severe
      headache, autonomic nervous system dysfunction and, in some patients, aura, and disabling
      neurological symptoms. Worldwide, migraine prevalence is as high as 18% in the general
      population. Increased frequency of patent foramen ovale (PFO) in migraineurs was first
      reported in 1998 in a case-control study. Since then, others have described a 60% prevalence
      of PFO in patients suffering from migraine with aura. The presence of a right-to-left shunt
      (RLS) is thought to be a potent trigger of migraine attacks, although the mechanism is
      unknown. Moreover, PFO closure has correlated with improved migraine symptoms in several
      retrospective uncontrolled studies. The aim of this single-center, prospective study is to
      assess the impact of PFO closure on migraine attacks over time together with evaluation of
      potential predictive risk factors.
    

Detailed description: 
      The Study will evaluate the results of approximately 100 subjects from a single center study
      registered in this trial. Subjects who experienced transient ischemic attack (TIA) or stroke
      with a clinical indication to PFO closure and symptomatic for migraine with/o aura are
      considered for a migraine score analysis at baseline before PFO closure and during the
      subsequent follow-up (FU) at 6 and 12-months, together with lab evaluation for platelet
      reactivity tests (P selectin, Thromboxane B2), Prostaglandin E1 and 2 (PGE1, PGE2),
      serotonin, cytokines and prostaglandin PGE1 urinary metabolite run under aspirin therapy.

      The research questions are as follows:

      Does the presence of a large PFO have any impact on migraine with aura?

      Do migraineurs with aura and PFO have higher biomarkers of platelet activation than control
      patients? and are they at higher risk of stroke and TIA recurrences based on high on
      clopidogrel platelet reactivity?

      What is the effect of PFO severity on monthly migraine frequency and aura frequency?

      What is the result of PFO closure in migraineur patients with PFO? Do Migraine with aura
      patients with large PFO have higher platelet activation and better migraine resolution after
      PFO closure?
    

Intervention name(s): patent foramen ovale closure
Intervention type(s): Device
Intervention description(s): Pts undergoing PFO closure will receive 2-months of DAPT and 6 months of aspirin after patent foramen ovale (PFO) closure; they will be compared to healthy subjects on aspirin treatment
Other intervention name(s): Occlutech Figulla Flex II PFO device; aspirin
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: patients treated with PFO closure Group 2: Healthy subjects on Aspirin therapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine;; PFO; platelet reactivity; aura