CompletedNot Applicable

pLatelEts And MigRaine iN patEnt foRamen Ovale

Italy90 participantsStarted 2018-02-15

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients older than 18 years with more than 2 criteria: * Previous Stroke or TIA (transient ischemic attack) * positive MRI for ischemic events - * PFO with a baseline R-L shunt \> 10 microembolic signals (MES) and \> 20 MES during/after Valsalva Manoeuver * Atrial septal aneurysm (ASA) or residual Chiari network or Eustachian Valve * positive Thrombophilic screening (MTHFR/prot C/Prot S) * Ability to sign the informed consent for the study participation Exclusion Criteria: * Patients older than 70 years * Paroxysmal Atrial fibrillation * Carotid, vertebral or basilar artery stenosis\> 50% on duplex imaging * Inadequate temporal bone windows (signals) for transcranial Doppler insonation * medication overuse headache * history of cognitive dysfunction, epilepsy, brain injury * use of continuous positive airway pressure (CPAP) within 6 months of study enrollment * Left Ventricular Ejection Fraction (LVEF) \< 30% * Moderate/severe mitral valve regurgitation * Known Allergy to aspirin * Known allergy to nickel * Severe chronic kidney disease (GFR \< 30 ml/min) * Beck depression inventory score \> or= 29 * State-trait anxiety inventory score exceeding cut-off for are and sex Keywords: PFO, migraine, migraine with aura, aura, platelets

What they're measuring

Change in Migraine Characteristics

Timeframe: The outcome data were evaluated at 6-months and 12-months after PFO closure and compared to baseline

Migraine Assessment by Anzola's Score

Timeframe: Baseline, 6 months and 12-months after PFO closure

Trial details

NCT IDNCT03521193

SponsorCentro Cardiologico Monzino

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-31

Results submitted2021-07-27