Clinical trial NCT01391091: Effect of Catheter Ablation on Clinical Course of Migraine in AF Patients With or Without Previous History of Migraine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Atrial Fibrillation
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Incidence of thrombo-embolic events and migraine
timeFrame: 6 and 12 months post-ablation
Secondary outcomes:
measure: Impact of therapeutic Coumadin on the prevalence and clinical course of migraine in patients with a previous history
timeFrame: 6 and 12 months post-ablation
Other outcomes:
Locations:
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Luigi Di Biase, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: