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临床试验/NCT01391091
NCT01391091已完成3 期

Effect of Catheter Ablation on the Prevalence, Clinical Manifestation and MRI Findings of Migraine in AF Patients With or Without a Previous History of Migraine

Texas Cardiac Arrhythmia Research Foundation2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
173
试验地点
2
主要终点
Incidence of thrombo-embolic events and migraine

研究概览

简要总结

The purpose of this prospective study is to evaluate the effect of catheter ablation on incidence, prevalence and disease-severity of migraine in AF patients undergoing ablation, with or without a history of migraine.

详细描述

Migraine, a neurovascular disorder affecting approximately 12% of world population, is characterized by recurrent attacks of incapacitating headache associated with photophobia, phonophobia, nausea and vomiting (1). Although the pathogenesis of migraine is not clearly understood yet, it has been widely accepted as being caused by cerebral vasodilatation, abnormal neurological firings and/or neurogenic dural inflammation (1). Additionally, recent studies have demonstrated an association between migraine with aura and intracardiac shunting by a patent foramen ovale (PFO) leading to a hypothesis that paradoxical brain embolism of platelets and other undefined chemical substances can play a causal role in migraine with aura (2).

Radiofrequency catheter ablation (RFCA) has been shown to be a promising treatment for cardiac arrhythmias. During catheter ablation, trans-septal puncture (TSP) is routinely performed to gain access to the left heart. TSP causes an iatrogenic atrial septal defect (ASD) with a transient right-to-left shunt which can predispose patients to stroke and migraine (3). In two different studies, with 571 and 183 patients in whom TSP was performed, the incidence of migraine was 0.5% and 2.2% respectively and the migraine was transient and resolved without any sequelae (2, 3). In separate studies, complete resolution or improvement of migraine was noticed with the ASD/PFO closure (4). Additional case-studies have also reported AF occurring during episodes of migraine with aura where the cardiac rhythm was normal between the episodes (5). All these reports evidently demonstrate an association between AF, TSP during RFCA and migraine, but fail to clearly define the nature of it. It is not yet understood whether a successful catheter ablation of AF has any impact on the natural course of pre-existing or newly-occurring migraine. This study aims at exploring the relationship between AF and migraine and to evaluate if an effective ablation therapy for AF influences the incidence and clinical presentation of migraine in patients with or without a previous history.

Several isolated case-studies have reported improvement in the frequency and severity of migraine during treatment with Coumadin (6, 7). Coumadin is routinely prescribed to patients undergoing RFCA to prevent thrombo-embolic events. Our study would further explore the impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history.

Hypothesis

Catheter ablation affects the disease course of migraine in AF patients with or without a previous history of migraine.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-75 years
  • AF patients undergoing RFCA
  • Ability to distinguish migraine attacks as discrete from other headaches (i.e., tension-headache)
  • Ability to read, comprehend, and legibly and reliably record information
  • Ability to provide written, informed consent

排除标准

  • Uncontrollable hypertension
  • History of stroke, TIA or epilepsy
  • Bleeding disorder
  • Hypersensitivity, allergy or contraindications to the use of NSAIDs, Triptans, Aspirin or Warfarin
  • Contraindication to undergoing an MRI

结局指标

主要结局

Incidence of thrombo-embolic events and migraine

时间窗: 6 and 12 months post-ablation

次要结局

  • Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history(6 and 12 months post-ablation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Natale

Medical director

Texas Cardiac Arrhythmia Research Foundation

研究点 (2)

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