Cardiac Arrhythmias in Refractory Epilepsy: identifying prevalence and LINKage between seizures and arrhythmias (CARELINK) - cardiac arrhythmias in epilepsy: the CARELINK-study

Stichting Epilepsie Instellingen Nederland0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•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

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