Migraine Relief After Patent Foramen Ovale Closure: a Single Center Analysis
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|ClinicalTrials.gov Identifier: NCT03521193|
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Platelet Aggregation, Spontaneous Migraine With Aura Patent Foramen Ovale||Device: patent foramen ovale closure||Not Applicable|
The Study will evaluate the results of approximately 100 subjects from a single center study registered in this trial. Subjects who experienced transient ischemic attack (TIA) or stroke with a clinical indication to PFO closure and symptomatic for migraine with/o aura are considered for a migraine score analysis at baseline before PFO closure and during the subsequent follow-up (FU) at 6 and 12-months, together with lab evaluation for platelet reactivity tests (P selectin, Thromboxane B2), Prostaglandin E1 and 2 (PGE1, PGE2), serotonin, cytokines and prostaglandin PGE1 urinary metabolite run under aspirin therapy.
The research questions are as follows:
Does the presence of a large PFO have any impact on migraine with aura?
Do migraineurs with aura and PFO have higher biomarkers of platelet activation than control patients? and are they at higher risk of stroke and TIA recurrences based on high on clopidogrel platelet reactivity?
What is the effect of PFO severity on monthly migraine frequency and aura frequency?
What is the result of PFO closure in migraineur patients with PFO? Do Migraine with aura patients with large PFO have higher platelet activation and better migraine resolution after PFO closure?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Migraine Characteristics in Patients Undergoing PFO (Patent Foramen Ovale) Closure: Evaluation of a Specific Risk Profile|
|Actual Study Start Date :||February 15, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Migraine evaluation in PFO patients
Patients symptomatic for migraine with/o aura and addressed to patent foramen ovale closure (Occlutech Figulla Flex II PFO occluder device) for a previous ischemic event, will receive dual antiplatelet therapy (DAPT) for 2 months after procedure and aspirin alone subsequently. Patients will undergo evaluation of platelet reactivity, serotonin and cytokines before PFO closure with a dedicated device and at 6 months follow-up
Device: patent foramen ovale closure
Pts will receive 2-months of DAPT and 6 months of aspirin after patent foramen ovale (PFO) closure
Other Name: Occlutech Figulla Flex II PFO device; aspirin
- Migraine and aura [ Time Frame: Baseline and 6 months ]
The change in migraine severity, incidence and duration with or without aura as measured by the Anzola's score Anzola's score: Duration 0=No pain 1=<6 hours 2=6-12 hours 3=>12 hours Frequency 0=No pain 1=1-4/month 2=5-9/month 3=>10/month Aura 0=No aura
1=Aura in ≥1 attack
- Platelet activation [ Time Frame: baseline and 6 months ]Platelet poor plasma levels of P selectin and serum concentration of B2-thromboxane (TXB2). (Plasma levels of P-selectin: ng/ml; Serum TXB2: ng/ml)
- Platelet reactivity tests [ Time Frame: baseline and 6 months ]
Verify-now Platelet Reactivity Unit (PRU): measures the P2Y12 platelet receptor blockade and platelet response to aspirin by an arachidonic acid initiated reaction. Verify-Now P2Y12 (PRU): Cut off: 208;
-Verify-Now Aspirin (Apirin Reactivity Unit (ARU): Cut off: 550
- Clinical outcomes [ Time Frame: In hospital, six and 12 months follow-up ]Absence of TIA and stroke recurrences after PFO closure and during the follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521193
|Contact: Alessandra Terragnifirstname.lastname@example.org|
|Centro Cardiologico Monzino, IRCCS||Recruiting|
|Milan, MI, Italy, 20138|
|Contact: Alessandra Terragni +390258002675 email@example.com|
|Principal Investigator: Daniela Trabattoni, MD, FACC|
|Principal Investigator:||Daniela Trabattoni, MD||Centro Cardiologico Monzino, IRCCS|