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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

193 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-16

Study Completion Date

2019-12-15

Brief Summary

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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

Detailed Description

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Conditions

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Epilepsy

Keywords

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Epilepsy heart block sudden cardiac death loop recorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

References

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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.hrcr.2018.11.014. eCollection 2019 Mar. No abstract available.

Reference Type RESULT

PMID: 30891410 (View on PubMed)

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. 2021 Feb;18(2):221-228. doi: 10.1016/j.hrthm.2020.09.002. Epub 2020 Sep 8.

Reference Type RESULT

PMID: 32911052 (View on PubMed)

Other Identifiers

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09-04/15 - 6

Identifier Type: -

Identifier Source: org_study_id