An observational study in Epilepsy, sponsored by National Research Center for Preventive Medicine. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-12-07.
Sponsored by National Research Center for Preventive Medicine · Observational
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
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 193 is above the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →National Research Center for Preventive Medicine is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with hard-to-treat epilepsy without known cardiac disease and beta-blockers therapy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Time frame: 3 years or until the end-of-battery life of Reveal XT, whichever came first
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
No study locations are listed for this record.
Plan to share: Undecided
Ran from Nov 2015 to primary completion in Dec 2019, 48 months.
Of 193 non-industry observational studies under Epilepsy, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 179. This study's 48 months is below that.
Counting every sponsor, half of 230 studies reached it within 59 months; a quarter within 24 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Research Center for Preventive Medicine