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

Centro Cardiologico Monzino

Status: Enrolling

Conditions: PFO - Patent Foramen Ovale; Migraine Headache

Treatments: Other: blood samples collection

Study type: Observational

Funder types: Other

Identifiers

NCT06046508

CCM 1934

Details and patient eligibility

About

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 from patients with incidental PFO. The study will also explore additional distinguishing features of causal and incidental PFO using a metabolomics approach. It involves the enrollment of well-characterized patient cohorts and an ex vivo approach using comparative cell biology models that reproduce the most critical aspects of the clinical scenario.

Full 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 clinical practice:

• thrombophilic screening (factor V and II and MTHFR gene mutation); sampling for homocysteine, Protein C (Prot C), Protein S (Prot S) and antithrombin III assay;
• anatomic evaluation of the SIA (Saccular intracranial aneurysm) by color-doppler TT echocardiogram and intracardiac ultrasound for definition of the anatomy of the fossa ovalis: tunneled appearance; absence of SIA aneurysm; bulging of the SIA; convex right/left SIA aneurysm;
• quantification of right-left intracardiac shunt by CT doppler;
• classification of migraine according to Anzola scale at baseline visit, post PFO correction, at follow-up at 6 and 12 months.

For the purpose of the study, blood sampling will be performed for evaluation of platelet reactivity; oxidative stress, aggregability, and deformability of red blood cells; and isolation of Endothelial Colony Forming Cells (ECFCs) for analysis of endothelial function. The latter in particular will be evaluated in comparison with the endothelial function of 30 subjects without known disease with age > 18 years, enrolled as a control group.

All analyses will be performed before PFO correction and 180 days after surgery.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

120 participants in 1 patient group

Sigle arm study

Description:

Patients with migraine headache with aura (MHA), patent foramen ovale (PFO) and previous neurological event (transient ischemic attack -TIA- or stroke) with clinical indication for percutaneous correction of the defect according to guidelines will be enrolled

Treatment:

Other: blood samples collection