Focal Epilepsy Clinical Trial
— LOOPOfficial title:
Long-term Cardiac Monitoring in Epilepsy: Comparative Group Study to Assess Risk of Interictal and Ictal Cardiac Dysfunction
NCT number | NCT03955432 |
Other study ID # | 18-0820 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 19, 2019 |
Est. completion date | January 3, 2023 |
Verified date | February 2023 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 3, 2023 |
Est. primary completion date | November 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwell | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health | Medtronic |
United States,
Akalin F, Tirtir A, Yilmaz Y. Increased QT dispersion in epileptic children. Acta Paediatr. 2003 Aug;92(8):916-20. doi: 10.1080/08035250310003550. — View Citation
Antzelevitch C, Burashnikov A. Overview of Basic Mechanisms of Cardiac Arrhythmia. Card Electrophysiol Clin. 2011 Mar 1;3(1):23-45. doi: 10.1016/j.ccep.2010.10.012. No abstract available. — View Citation
DeGiorgio CM, DeGiorgio AC. SUDEP and heart rate variability. Epilepsy Res. 2010 Aug;90(3):309-10; author reply 311-2. doi: 10.1016/j.eplepsyres.2010.03.013. Epub 2010 Apr 15. No abstract available. — View Citation
Drake ME, Reider CR, Kay A. Electrocardiography in epilepsy patients without cardiac symptoms. Seizure. 1993 Mar;2(1):63-5. doi: 10.1016/s1059-1311(05)80104-9. — View Citation
Heron SE, Scheffer IE, Berkovic SF, Dibbens LM, Mulley JC. Channelopathies in idiopathic epilepsy. Neurotherapeutics. 2007 Apr;4(2):295-304. doi: 10.1016/j.nurt.2007.01.009. — View Citation
Johnson JN, Tester DJ, Bass NE, Ackerman MJ. Cardiac channel molecular autopsy for sudden unexpected death in epilepsy. J Child Neurol. 2010 Jul;25(7):916-21. doi: 10.1177/0883073809343722. Epub 2010 Apr 15. — View Citation
Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18. — View Citation
Neufeld G, Lazar JM, Chari G, Kamran H, Akajagbor E, Salciccioli L, Kassotis J, Stewart M. Cardiac repolarization indices in epilepsy patients. Cardiology. 2009;114(4):255-60. doi: 10.1159/000233236. Epub 2009 Aug 12. — View Citation
Rugg-Gunn FJ, Simister RJ, Squirrell M, Holdright DR, Duncan JS. Cardiac arrhythmias in focal epilepsy: a prospective long-term study. Lancet. 2004 Dec 18-31;364(9452):2212-9. doi: 10.1016/S0140-6736(04)17594-6. — View Citation
So NK, Sperling MR. Ictal asystole and SUDEP. Neurology. 2007 Jul 31;69(5):423-4. doi: 10.1212/01.wnl.0000268698.04032.bc. No abstract available. — View Citation
Surges R, Henneberger C, Adjei P, Scott CA, Sander JW, Walker MC. Do alterations in inter-ictal heart rate variability predict sudden unexpected death in epilepsy? Epilepsy Res. 2009 Dec;87(2-3):277-80. doi: 10.1016/j.eplepsyres.2009.08.008. Epub 2009 Sep 10. — View Citation
Tao JX, Qian S, Baldwin M, Chen XJ, Rose S, Ebersole SH, Ebersole JS. SUDEP, suspected positional airway obstruction, and hypoventilation in postictal coma. Epilepsia. 2010 Nov;51(11):2344-7. doi: 10.1111/j.1528-1167.2010.02719.x. Epub 2010 Sep 24. — View Citation
Tavernor SJ, Brown SW, Tavernor RM, Gifford C. Electrocardiograph QT lengthening associated with epileptiform EEG discharges--a role in sudden unexplained death in epilepsy? Seizure. 1996 Mar;5(1):79-83. doi: 10.1016/s1059-1311(96)80067-7. — View Citation
Velagapudi P, Turagam M, Laurence T, Kocheril A. Cardiac arrhythmias and sudden unexpected death in epilepsy (SUDEP). Pacing Clin Electrophysiol. 2012 Mar;35(3):363-70. doi: 10.1111/j.1540-8159.2011.03276.x. Epub 2011 Nov 29. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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