Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06046508
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-08-21
Brief Title:
Migraine With Aura and Patent Foramen Ovale Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial MANET
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Migraine With Aura and Causal or Incidental Patent Foramen Ovale PFO Identification of Biomarkers to Select Patients Who Would Most Benefit From PFO Closure The MANET Study
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANET
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 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
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 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 rightleft 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
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 rightleft 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None