Long-term Cardiac Monitoring in Epilepsy

Study Overview
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Brief Summary
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The purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Patients with epilepsy have a higher risk for cardiac complications than the general population. With this study, we aim to understand more about these potential complications in patients with epilepsy and assess if treatments for cardiac problems should be evaluated more carefully in patients with epilepsy.

Detailed Description
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Most cardiac studies have investigated patients with intractable focal epilepsy who have a high risk for co-morbidities, accidents, injury and SUDEP. This is confounded by the major antiepileptic drug burden in this population. Very little, however, is known about the risk of cardiac arrhythmias in patients with a lower seizure burden, i.e. patients with infrequent focal seizures and/or those without secondarily generalized convulsions. Furthermore, no chronic cardiac data is available in patients with epileptic encephalopathies especially given the fact that some of these patients are known to carry mutations that increase the risk for cardiac arrhythmias.In addition, periods of reduced cerebral blood flow during tachy or brady arrhythmias may exacerbate seizure severity and during. Diagnosing and treating these arrhythmias may not only prevent adverse cardiac events, but also reduce seizure burden. This study primarily aims to compare the frequency of cardiac rhythm abnormalities in patients with epilepsy of different severity, assess the long-term cardiac risk and evaluate the possible preventive role of anti-arrhythmic agents and/or cardiac pacemaker/defibrillator needs.

Official Title
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Long-term Cardiac Monitoring in Epilepsy: Comparative Group Study to Assess Risk of Interictal and Ictal Cardiac Dysfunction

Conditions
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Focal Epilepsy, Intractable Epilepsy, Epileptic Encephalopathy, Lennox Gastaut Syndrome, Symptomatic Epilepsy, Generalized Epilepsy

Intervention / Treatment
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* Device: Reveal LINQ ICM System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50 years with ability to consent. No primary cardiac abnormality. Ability to receive an implantable loop recorder and tolerate the procedure. Patients with epilepsy as described by the three groups (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy) Exclusion Criteria: Cardiac disease of any type Known epilepsy genetic disorder with potential cardiac compromise Major co-morbidities such as cancer, diabetes, stroke, bleeding disorder Chronic psychosis Severe MR without reliable caregiver monitoring (what is MR?) Already included in another clinical trial that will affect the objectives of this study. Life expectancy is less than 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LINQ ICM<br>The LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population. The LINQ ICM is approved by the FDA for use in patients where there is a suspicion of occult cardiac arrhythmias and is therefore being utilized in this study in accordance with the FDA labeling. | Device: Reveal LINQ ICM System<br>* The LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of an event (i.e., arrhythmia or seizure) | Ratio of the total number of observed events divided by the number of person-days at risk in that group. Arrhythmias will be classified into different categories based on the observed data. Arrhythmia of any type, as well as specific categories of arrhythmias will be analyzed separately. | During the two years of monitoring |