Status:
UNKNOWN
Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)
Lead Sponsor:
Centro Cardiologico Monzino
Collaborating Sponsors:
IRCCS Policlinico S. Donato
Università di Cagliari
Conditions:
Migraine Headache
PFO - Patent Foramen Ovale
Eligibility:
All Genders
18-65 years
Brief Summary
This is a multicenter prospective observational study aimed to asses whether a specific prothrombotic platelet phenotype can discern migraine patients with PFO (patent forame ovale) - related symptoms...
Detailed Description
Patients with PFO, who meet all the inclusion and none of the exclusion criteria, will be enrolled in the study. Patients will undergo percutaneous correction of PFO and the following evaluations as c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06046508
Start Date
May 18 2023
End Date
April 1 2025
Last Update
February 8 2024
Active Locations (3)
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1
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
2
Università di Cagliari
Cagliari, Italy, 09124
3
Azienda Ospedaliera Universitaria "Federico II"
Napoli, Italy, 80131