Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 04/30/2015 |
| First Submitted: | 05/25/2011 |
| Estimated Enrollment Submitted: | 07/06/2011 |
| First Posted: | 07/10/2011 |
| Last Update Submitted: | 10/16/2016 |
| Last Update Posted: | 10/17/2016 |
| Actual Study Start Date: | 11/30/2010 |
| Estimated Primary Completion Date: | 03/31/2013 |
| Estimated Study Completion Date: | 03/31/2014 |
Condition or disease
Intervention/treatment
Procedure: Patients without history of migraine
Procedure: Patients with history of migraine
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Patients without history of migraine Incidence and prevalence of migraine episodes in the post-ablation period | Procedure: Patients without history of migraine PVAI |
| Active Comparator: Patients with history of migraine Incidence and prevalence of migraine episodes in the post-ablation period | Procedure: Patients with history of migraine PVAI |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. Incidence of thrombo-embolic events and migraine [6 and 12 months post-ablation]
Secondary Outcome Measures
1. Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history [6 and 12 months post-ablation]
