Migraine in Patients Undergoing PFO (Patent Foramen Ovale) Closure: Evaluation of a Platelet-associated Pathophysiologic Linking Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Migraine Characteristics
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years with more than 2 criteria:
- •Previous Stroke or TIA (transient ischemic attack)
- •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
排除标准
- •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
结局指标
主要结局
Change in Migraine Characteristics
时间窗: The outcome data were evaluated at 6-months and 12-months after PFO closure and compared to baseline
The evaluation in absolute numbers of patients fully responders, non-responders or with a moderate benefit on migraine symptoms after PFO Closure was performed
Migraine Assessment by Anzola's Score
时间窗: Baseline, 6 months and 12-months after PFO closure
The change in migraine severity, incidence and duration with or without aura as measured by the Anzola's score (The score is the expression of the sum of each corresponding value referring to migraine duration, frequency and the presence or absence of aura). The minimum value was 2 and the maximum 9; the higher the value, worse is the migraine classification. 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
次要结局
- Platelet Activation (I)(baseline and 6 months after PFO closure)
- Platelet Aggregation (I)(baseline and 6 months after PFO Closure)
- Platelet Activation (II)(Baseline and 6 months after PFO closure)
- Clinical Outcomes(In hospital, six and 12 months follow-up)
- Platelet Activation (III)(baseline and six months after PFO closure)
- Platelet Activation (IV)(Baseline and six-months after PFO closure)
研究者
Daniela Trabattoni
MD, FACC
Centro Cardiologico Monzino