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| Name | Class |
|---|---|
| IRCCS Policlinico S. Donato | OTHER |
| Università di Cagliari | UNKNOWN |
| Federico II University | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sigle arm study | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood samples collection | Other | patients, who meet all the inclusion criteria and none of the exclusion criteria, will be enrolled and they will perform a blood withdrawal before PFO correction and 180 days after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of migraineurs patients with Platelet activation | Fresh whole blood will be stained for tissue factor (TF) expression, platelet activation markers [P-selectin and activated glycoprotein IIbIIIa] and annexinV binding to phosphatidylserine (PS). Flow cytometry analysis will be performed on fixed samples. Platelet procoagulant potential will be assessed by thrombin generation assay. The CAT assay (Chloramphenico Acetyltransferase) lwill be performed in the presence of a neutralizing anti-Tisse Factor (aTF) antibody (Ab) to assess the contribution of TF, and by adding an excess of exogenous phospholipids. | through study completion, an average of 2 years |
| Number of migraineurs patients with high Thrombin generation levels | Flow cytometry MV characterization will be performed on stored patients' plasma samples. On the same plasma samples, MV procoagulant potential will be assessed by thrombin generation assay. | through study completion, an average of 2 years |
| levels of the oxidative status in PFO patients | RBC (red blood cells) deformability and aggregability, generation of oxygen radicals in RBC and platelets of the overall enrolled population will be analyzed at T0 and at T1. Systemic redox status will be quantified by evaluating concentrations of both reduced glutathione (GSH) and its oxidized form GSSG (oxidized glutathione) on stored samples. | through study completion, an average of 2 years |
| Number of migraineurs patients with Untargeted metabolomics | The metabolomic patterns of plasma, urine and platelets/ECFC (endothelial-colony forming cells) of the enrolled population will be investigated by a combined use of spectroscopy and multivariate and univariate statistical tools in order to identify the molecular fingerprint that could build a score able to identify patients with incidental PFO. | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Elucidate whether mechanical stress related to the right-to-left shunt may influence Erythrocyte behavior affecting in turn oxidative stress status | This will be accomplished ex vivo by using a microfluidic platform that recapitulates the specific shear stress profiles to which blood is exposed as it flows through the PFO | through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with MHA, PFO and previous neurological event (TIA or stroke) with clinical indication for percutaneous correction of the defect according to guidelines.
As a control group, 30 subjects without known disease with age > 18 years will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Trabattoni, MD | Contact | 0285800 | 2780 | daniela.trabattoni@cardiologicomonzino.it |
| Marina Camera, PhD | Contact | 025800 | 2255 | marina.camera@cardiologicomonzino.it |
| Name | Affiliation | Role |
|---|---|---|
| Daniela Trabattoni, MD | IRCCS Centro Cardiologico Monzino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Donato | Recruiting | San Donato Milanese | Milan | 20097 | Italy |
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blood samples will be used for platelet and erythrocyte function analysis and assessment of endothelial function
| Assess whether a unique endothelial dysfunction profile identifies migraineurs with incidental PFO | Functional profiling will be carried out, by measuring proliferation, migration and in vitro angiogenesis. The pro-inflammatory and pro-thrombotic phenotype of the cells will be assessed using a panel of molecular markers. Platelet adhesion will be determined on resting and activated ECFC under flow conditions; thrombin generation will be measured using a cell-based assay. | through study completition, an average of 2 years |
| Università di Cagliari | Active, not recruiting | Cagliari | 09124 | Italy |
| Azienda Ospedaliera Universitaria "Federico II" | Not yet recruiting | Naples | 80131 | Italy |
|
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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