Identifying biomarkers in migraine patients with a heart condition
Migraine With Aura and Causal or Incidental Patent Foramen Ovale (PFO): Identification of Biomarker(s) to Select Patients Who Would Most Benefit From PFO Closure. The MANET Study
This study is testing if certain blood markers can help doctors tell the difference between migraine patients with a specific heart condition and those who have it by chance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 3 sites (San Donato Milanese, Milan and 2 other locations) |
| Trial ID | NCT06046508 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to determine if a specific prothrombotic platelet phenotype can differentiate migraine patients with a patent foramen ovale (PFO) from those with incidental PFO. The study will enroll patients with PFO who meet specific criteria and will conduct various evaluations, including thrombophilic screening and imaging studies. Blood samples will be collected to assess platelet reactivity and endothelial function, with analyses performed before and after PFO correction. The goal is to identify biomarkers that could guide treatment decisions for migraine patients with PFO.
Who should consider this trial
Good fit: Ideal candidates include patients with a patent foramen ovale who have experienced a stroke or transient ischemic attack and meet specific inclusion criteria.
Not a fit: Patients with conditions such as severe chronic kidney disease or those requiring long-term anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more targeted interventions for migraine patients with PFO, potentially improving their treatment outcomes.
How similar studies have performed: While this approach is novel in its specific focus on migraine and PFO, similar studies have shown promise in identifying biomarkers for other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * presence of PFO with right-left shunt at baseline \> 10 MES and during Valsalva \> 20 MES * previous Stroke or TIA * positive MRI for ischemic outcomes * SIA aneurysm or residual Chiari/Eustachian valve network * thrombophilic screening positivity (MTHFR/prot C/prot S) * cability to sign informed consent for study participation and adherence to planned clinical follow-ups Exclusion Criteria: * paroxysmal/refractory atrial fibrillation * TSA vasculopathy * left ventricular ejection fraction \<30% * moderate/severe mitral valve regurgitation * need for long-term anticoagulant therapy * allergy or intolerance to antiplatelet therapy * nickel allergy * severe chronic kidney disease (GFR \< 30 mL/min)
Where this trial is running
San Donato Milanese, Milan and 2 other locations
- IRCCS Policlinico San Donato — San Donato Milanese, Milan, Italy (Recruiting)
- Università di Cagliari — Cagliari, Italy (Active_not_recruiting)
- Azienda Ospedaliera Universitaria "Federico II" — Napoli, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Daniela Trabattoni, MD — IRCCS Centro Cardiologico Monzino
- Study coordinator: Daniela Trabattoni, MD
- Email: daniela.trabattoni@cardiologicomonzino.it
- Phone: 0285800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.