Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06046508
Study type Observational
Source Centro Cardiologico Monzino
Contact Daniela Trabattoni, MD
Phone 0285800
Email daniela.trabattoni@cardiologicomonzino.it
Status Recruiting
Phase
Start date May 18, 2023
Completion date April 2025

See also
  Status Clinical Trial Phase
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Not yet recruiting NCT05943457 - Vitamin K2 Supplementation in Adult Episodic Migraine N/A
Completed NCT01211145 - Zomig - Treatment of Acute Migraine Headache in Adolescents Phase 4
Completed NCT00530517 - A Study on the Usability of the Needle-free Intraject® System in Adult Patients During Acute Migraine Attack Phase 2
Completed NCT00898677 - Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030) Phase 3
Recruiting NCT06459635 - Migraine Attack Pain Phase Prediction Study
Completed NCT03971071 - A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache Phase 4
Withdrawn NCT02706015 - Cefaliv® Compared to Neosaldina® in the Treatment of Migraine Attacks Phase 3
Completed NCT02518464 - Ticagrelor Therapy for RefrACTORy Migraine Study Phase 4
Terminated NCT02375789 - Intranasal Cooling for Symptomatic Relief of Migraine N/A
Terminated NCT00391755 - A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches Phase 4
Completed NCT03401346 - Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults Phase 1
Completed NCT05085483 - Ketone for Migraine Prevention N/A
Completed NCT01604785 - Low-dose Propofol for Pediatric Migraine Phase 2/Phase 3
Terminated NCT00804973 - Study in Participants With Acute Migraines Headaches Phase 2
Completed NCT03341689 - Psilocybin for the Treatment of Migraine Headache Phase 1
Completed NCT01630044 - Neurostimulation Device for Treatment of Migraine Headache N/A
Active, not recruiting NCT00285402 - Efficacy and Safety Clinical Trial of Intranasal AST-726 for the Prevention of Migraine Phase 2
Completed NCT00203255 - Clinical Study Examining Use of an Over-the-Counter Supplement for the Prevention of Menstrually-Associated Migraine Headache N/A
Active, not recruiting NCT04584762 - Automated Variable Pattern Insufflator Device (AVPI) for the Acute Treatment of Migraine N/A