View Clinical Trial (Medical Research Study)
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
| City: |
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Austin |
| State: |
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Texas |
| Zip Code: |
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78705 |
| Conditions: |
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Migraine - Atrial Fibrillation |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01391091 |
| Primary Contact: |
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Principal Investigator
Andrea Natale, MD
Texas Cardiac Arrhythmia Research Foundation
Andrea Natale
Email: dr.natale@gmail.com
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| Backup Contact: |
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Email: mitra.mohanty@stdavids.com
Mitra Mohanty, MD
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| Location Contact: |
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Austin, Texas 78705
United States
Andrea Natale, MD
Phone: 512-544-8186
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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