Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

Launched by CENTRO CARDIOLOGICO MONZINO · Sep 12, 2023

Keywords

ClinConnect Summary

The MANET trial is a research study that aims to better understand migraines, particularly those associated with a condition called patent foramen ovale (PFO), which is a small hole in the heart. The researchers are looking to identify specific characteristics in patients with migraines and PFO that could help determine who would benefit from certain treatments. This study involves examining blood samples and other factors to see how they relate to migraine symptoms and PFO. The goal is to find ways to distinguish between patients who genuinely need intervention for their migraines and those who have PFO but may not require treatment.

To participate in this study, individuals should be between the ages of 65 and 74 and have a confirmed PFO along with certain medical conditions, such as a previous stroke or specific blood test results. Participants will be closely monitored and may undergo various tests to gather information for the study. It’s important for potential participants to be able to provide informed consent and commit to follow-up appointments. This trial is currently recruiting participants and is open to anyone, regardless of gender.

Gender

ALL

Eligibility 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)