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

NCT03376087 | Completed

• 1 other identifier: 09-04/15 - 6
• Study Type: observational
• Target: 193
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Epilepsy

Keywords

Epilepsy; heart block; sudden cardiac death; loop recorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with hard-to-treat epilepsy without known cardiac disease and beta-blockers therapy

You may qualify if:

• Hard-to-treat focal epilepsy
• Aged 18 to 60 years
• If female not pregnant

You may not qualify if:

• Known clinical relevant structural cardiac disease
• Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
• Use of beta blockers or other antiarrhythmic medication
• Diagnosis of psychogenic non-epileptic seizures

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead
• Pirogov Russian National Research Medical University: collaborator

Related Publications (2)

• 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.

  PMID: 30891410 RESULT

• 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.

  PMID: 32911052 RESULT

MeSH Terms

Conditions

Epilepsy; Heart Block; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 18, 2017
• Study Start: November 16, 2015
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: December 7, 2020

Record last verified: 2020-12