Clinical trial NCT03955432: Long-term Cardiac Monitoring in Epilepsy
Official title: Long-term Cardiac Monitoring in Epilepsy: Comparative Group Study to Assess Risk of Interictal and Ictal Cardiac Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Focal Epilepsy
Intractable Epilepsy
Epileptic Encephalopathy
Lennox Gastaut Syndrome
Symptomatic Epilepsy
Generalized Epilepsy
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-05-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-50 years with ability to consent.
2. No primary cardiac abnormality.
3. Ability to receive an implantable loop recorder and tolerate the procedure.
4. Patients with epilepsy as described by the three groups (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy)

Exclusion Criteria:

1. Cardiac disease of any type
2. Known epilepsy genetic disorder with potential cardiac compromise
3. Major co-morbidities such as cancer, diabetes, stroke, bleeding disorder
4. Chronic psychosis
5. Severe MR without reliable caregiver monitoring (what is MR?)
6. Already included in another clinical trial that will affect the objectives of this study.
7. Life expectancy is less than 1 year

Primary outcomes:
measure: Incidence rate of an event (i.e., arrhythmia or seizure)
timeFrame: During the two years of monitoring
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Northwell
state: New York
Study officials:
References:
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