EpilepsyEpi-Loop-RecNCT03376087
Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders
An observational study of Epilepsy, run by National Research Center for Preventive Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2015to 15 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with hard-to-treat epilepsy without known cardiac disease and beta-blockers therapy
Who may be able to join
- Hard-to-treat focal epilepsy
- Aged 18 to 60 years
- If female not pregnant
Who cannot join
- 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
About this study
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
- Medical subject headings
- Epilepsy, Heart Block, Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 years or until the end-of-battery life of Reveal XT, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start16 Nov 2015
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- Pirogov Russian National Research Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376087
- Sponsor's protocol ID
- 09-04/15 - 6
- Acronym
- Epi-Loop-Rec
- Status last verified
- Dec 2020
- First submitted
- 28 Nov 2017
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30891410Serdyuk 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.
PubMed 32911052
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rhythm Disturbances in Hard-to-treat Epilepsy Patients Using Loop ECG Recorders
- ClinicalTrials.gov ID
- NCT03376087
- Acronym / sponsor ID
- Epi-Loop-Rec / 09-04/15 - 6
- Conditions
- Epilepsy
- Keywords
- Epilepsy, heart block, sudden cardiac death, loop recorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Collaborators
- Pirogov Russian National Research Medical University
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with hard-to-treat epilepsy without known cardiac disease and beta-blockers therapy
Key inclusion criteria (3 listed)
- Hard-to-treat focal epilepsy
- Aged 18 to 60 years
- If female not pregnant
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of a dysrhythmia
Time frame: 3 years or until the end-of-battery life of Reveal XT, whichever came first
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
1 secondary outcome
The number of patients who will have receive the permanent pacemaker at the end of the study.
Time frame: 3 years or until the end-of-battery life of Reveal XT, whichever came first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Results publication: PubMed 30891410Serdyuk 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.
- Results publication: PubMed 32911052Serdyuk 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by National Research Center for Preventive Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a dysrhythmia (time frame: 3 years or until the end-of-battery life of Reveal XT, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.