pLatelEts And MigRaine iN patEnt foRamen Ovale (NCT03521193) | Clinical Trial Compass
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Migraine Characteristics
Timeframe: The outcome data were evaluated at 6-months and 12-months after PFO closure and compared to baseline
2
Migraine Assessment by Anzola's Score
Timeframe: Baseline, 6 months and 12-months after PFO closure