N/A
N=90
pLatelEts And MigRaine iN patEnt foRamen Ovale
Platelet Aggregation, Spontaneous · Migraine With Aura · Patent Foramen Ovale
Bottom Line
View on ClinicalTrials.gov: NCT03521193 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Change in Migraine Characteristics — 43; 2; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- patent foramen ovale closure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centro Cardiologico Monzino
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Migraine Characteristics |
43; 2; 17 | — |
| PRIMARY Migraine Assessment by Anzola's Score |
7.2; 1.09; 1.1 | — |
| SECONDARY Platelet Activation (I) |
26.9; 30.6; 32.2; 32.1; 37.6; 37.8 | — |
| SECONDARY Platelet Activation (II) |
29.1; 12.3; 17.9 | — |
| SECONDARY Platelet Activation (III) |
1038; 781; 797 | — |
| SECONDARY Platelet Activation (IV) |
115.2; 63.4; 77.2 | — |
| SECONDARY Platelet Aggregation (I) |
153; 157; 187; 8.5; 8; 11 | — |
| SECONDARY Clinical Outcomes |
1; 0; 5; 0; 0; 0 | — |
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.
Eligibility Criteria
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) or= 29
- State-trait anxiety inventory score exceeding cut-off for are and sex
Keywords: PFO, migraine, migraine with aura, aura, platelets
Data sourced from ClinicalTrials.gov (NCT03521193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.