Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders

Epilepsy Clinical Trial

— Epi-Loop-Rec  

Official title:

Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376087
• Other study ID #: 09-04/15 - 6
• Status: Completed
• Start date: November 16, 2015
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2020
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death in epilepsy (SUDEP). Identification of these patients is challenging because cardiac rhythm disturbances could emerge only during seizures. Furthermore, patients could have transitioned sinus or AV node blocks which could cause syncopes with brady-related seizures which could be treated as epilepsy-related seizures. Implantable loop recorders have an ability to recording single-channel ECG for up to 36 months which give an ability to detect these heart disturbances.

The purpose of this study is to look the incidence and types of arrhythmias which occur in 150 patients with hard-to-treat partial seizures and secondarily generalized seizures

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Hard-to-treat focal epilepsy

2. Aged 18 to 60 years

3. If female not pregnant

Exclusion Criteria:

1. Known clinical relevant structural cardiac disease

2. Implanted pacemaker, including cardiac resynchronisation device, or defibrillator

3. Use of beta blockers or other antiarrhythmic medication

4. Diagnosis of psychogenic non-epileptic seizures

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Epilepsy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine	Pirogov Russian National Research Medical University

References & Publications (2)

Serdyuk S, Davtyan K, Burd S, Drapkina O, Boytsov S, Gusev E, Topchyan A. Cardiac arrhythmias and sudden unexpected death in epilepsy: Results of long-term monitoring. Heart Rhythm. 2020 Sep 8. pii: S1547-5271(20)30862-6. doi: 10.1016/j.hrthm.2020.09.002. — View Citation

Serdyuk S, Davtyan K, Burd S, Teryan R, Kharlap M, Drapkina O. A case of sudden unexpected death of a patient with epilepsy: Continuous electrocardiographic monitoring and autopsy results. HeartRhythm Case Rep. 2018 Nov 30;5(3):138-142. doi: 10.1016/j.hrc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a dysrhythmia	A dysrhythmia will be defined as either; asystole of =6 s; sinus bradycardia of =40 bpm during physical activity; 2nd or 3rd-degree AV-block; sinus tachycardia of =120 bpm; nonsustained and sustained monomorphic VT of =170 bpm; polymorphic VT; atrial fibrillation/flutter	3 years or until the end-of-battery life of Reveal XT, whichever came first
Secondary	The number of patients who will have receive the permanent pacemaker at the end of the study.		3 years or until the end-of-battery life of Reveal XT, whichever came first