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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
Sponsor:
Information provided by (Responsible Party):
Daniela Trabattoni, Centro Cardiologico Monzino

Brief Summary:
Migraine is a common, chronic neurovascular disorder characterized by attacks of severe headache, autonomic nervous system dysfunction and, in some patients, aura, and disabling neurological symptoms. Worldwide, migraine prevalence is as high as 18% in the general population. Increased frequency of patent foramen ovale (PFO) in migraineurs was first reported in 1998 in a case-control study. Since then, others have described a 60% prevalence of PFO in patients suffering from migraine with aura. The presence of a right-to-left shunt (RLS) is thought to be a potent trigger of migraine attacks, although the mechanism is unknown. Moreover, PFO closure has correlated with improved migraine symptoms in several retrospective uncontrolled studies. The aim of this single-center, prospective study is to assess the impact of PFO closure on migraine attacks over time together with evaluation of potential predictive risk factors.

Condition or disease Intervention/treatment Phase
Platelet Aggregation, Spontaneous Migraine With Aura Patent Foramen Ovale Device: patent foramen ovale closure Not Applicable

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Aspirin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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)

  2. 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


  3. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years with more than 2 criteria:
  • Previous Stroke or TIA
  • positive MRI for ischemic events -
  • PFO with a baseline R-L shunt > 10 microembolic signals (MES) and > 20 MES during/after Valsalva Manoeuver
  • Atrial septal aneurysm (ASA) or residual Chiari network or Eustachian Valve
  • positive Thrombophilic screening (MTHFR/prot C/Prot S)
  • Ability to sign the informed consent for the study participation

Exclusion Criteria:

  • Patients older than 70 years
  • Paroxysmal Atrial fibrillation
  • Carotid, vertebral or basilar artery stenosis> 50% on duplex imaging
  • Inadequate temporal bone windows (signals) for transcranial Doppler insonation
  • medication overuse headache
  • history of cognitive dysfunction, epilepsy, brain injury
  • use of continuous positive airway pressure (CPAP) within 6 months of study enrollment
  • Left Ventricular Ejection Fraction (LVEF) < 30%
  • Moderate/severe mitral valve regurgitation
  • Known Allergy to aspirin
  • Known allergy to nickel
  • Severe chronic kidney disease (GFR < 30 ml/min)
  • Beck depression inventory score > or= 29
  • State-trait anxiety inventory score exceeding cut-off for are and sex

Keywords: PFO, migraine, migraine with aura, aura, platelets


Information from the National Library of Medicine

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


Contacts
Contact: Alessandra Terragni +390258002675 alessandra.terragni@ccfm.it

Locations
Italy
Centro Cardiologico Monzino, IRCCS Recruiting
Milan, MI, Italy, 20138
Contact: Alessandra Terragni    +390258002675    alessandra.terragni@ccfm.it   
Principal Investigator: Daniela Trabattoni, MD, FACC         
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Daniela Trabattoni, MD Centro Cardiologico Monzino, IRCCS

Responsible Party: Daniela Trabattoni, MD, FACC, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT03521193     History of Changes
Other Study ID Numbers: CCM769
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniela Trabattoni, Centro Cardiologico Monzino:
Migraine;
PFO
platelet reactivity
aura

Additional relevant MeSH terms:
Migraine Disorders
Foramen Ovale, Patent
Migraine with Aura
Blood Platelet Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Hematologic Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors