Cardiac Arrhythmias in Refractory Epilepsy: identifying prevalence and LINKage between seizures and arrhythmias (CARELINK)
- Conditions
- 1000752110039911asystole cardiac arrhythmia
- Registration Number
- NL-OMON39798
- Lead Sponsor
- Stichting Epilepsie Instellingen Nederland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1) Drug-resistant focal epilepsy: failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom
2) * 1 seizure/month as indicated by history taking
3) If female, not pregnant
4) Aged 18 to 60 years*
5) Able to undergo the study procedure as judged by the treating physician.;*We have an instituted an age limit of 60 years in order to select a group of patients with as little comorbidity as possible, because this comorbidity could lead to asystole and other potentially dangerous arrhythmias irrespective of having epilepsy. In this pilot study it is important to maximize the power of a potential intervention (e.g. pacemaker implantation) after referral to a treating cardiologist based on the referral criteria we established: see also Section 3 STUDY DESIGN of the study protocol. In a larger follow-up study this age limit of 60 years can then be abandoned. For similar reasons, Nei et al. used an age limit of 50 years in their previous Reveal XT study of people with epilepsy.
1) Clinical suspicion of seizure-induced asystole (e.g. seizures with sudden flaccid falls)
2) Vagal nerve stimulator
3) Reveal implantation (either present or in the past)
4) Known clinical relevant structural cardiac disease
5) Family history of sudden death or hereditary syndromes that increase the risk of cardiomyopathy (e.g. Marfan*s disease)
6) ECG findings suggestive of arrhythmias without proper cardiac evaluation to in- or exclude this possibility. According to ESC guidelines on syncope the following ECG findings will be used: bifascicular block and other intraventricular conduction abnormalities, asymptomatic inappropriate sinus bradycardia (<50 bpm), sinoatrial block or sinus pause *3s in the absence of negative chronotropic medications, non-sustained VT, pre-exited QRS complexes, prolonged or short QT interval, Brugada pattern, pattern suggestive of arrythmogenic right ventricular cardiomyopathy.
7) Pacemaker
8) Use of beta blockers or other anti-arrhythmic/anti-arrhythmogenic medication (sotalol, amiodaron)
9) Previous diagnosis of psychogenic non-epileptic seizures
10) Patients who live alone and are not able to recall their seizures
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the and the two-year prevalence of clinically<br /><br>relevant arrhythmia. Clinical relevant asystole has been defined by the<br /><br>independent board as:<br /><br>1)Asystole of * 6s together with clinical symptoms (lightheadedness, syncope,<br /><br>seizure) as indicated by the seizure diary, SDM activation, or patient<br /><br>activation of Reveal XT. To establish relatedness between clinical symptoms and<br /><br>arrhythmias, the time frame between the reported and the recorded event should<br /><br>not exceed 15 min.<br /><br>2)Asystole of *10s regardless of report of clinical symptoms<br /><br>3)Any other cardiac arrhythmia of clinical significance as judged by the study<br /><br>cardiologists and approved as such by the independent board.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1)The number of participants who will have received a permanent pacemaker at<br /><br>the end of this study will serve as a secondary endpoint.<br /><br>2)The percentage of seizure-related cardiac arrhythmias<br /><br>3)The percentage of patients with a cardioinhibitory response to head-up<br /><br>tilt-testing</p><br>