Department of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Neurology, Sahlgrenska University Hospital, Member of Epicare, Gothenburg, Sweden.
Epilepsia Open. 2024 Aug;9(4):1611-1617. doi: 10.1002/epi4.12987. Epub 2024 Jun 14.
A growing body of evidence suggests patients with late-onset seizures are at an increased risk of stroke, but the potential for reducing cardiovascular morbidity through risk factor screening and management is unknown. We aim to determine whether individuals with new-onset unprovoked seizures after middle age should undergo vascular risk assessment. The long follow-up needed to assess stroke risk and the known benefit of vascular risk factor modification make a standard RCT logistically and ethically challenging. Instead, we propose and have developed a protocol for a cluster project assessing the effect of vascular risk factor screening in an intervention trial as well as a cohort study.
Participating neurology clinics will implement standard cardiovascular risk factor assessment into the routine evaluation for individuals aged ≥50 years attending their first specialized consultation after an unprovoked seizure, excluding those with progressive brain disease. The project has two interlinked components: a prospective single group trial, in which risk factor assessment is performed and subsequent management is followed for one year; and a register-based cohort study examining the long-term effects of the intervention on a system level by comparing patients attending initial consultations in the 2 years after start of the study, with patients seen in the four preceding years at the same clinics.
The primary outcome of the intervention trial is the proportion of patients receiving subsequent pharmacological treatment. The primary outcome of the cohort study is the incidence of acute stroke in the Swedish Stroke Register.
Swedish Ethical Review Authority approval (which is valid for 2 years only) will be sought when funding is obtained. The results will be disseminated through peer-reviewed scientific publications.
The study will be registered at clinicaltrials.gov.
A first seizure in a middle-aged or older person indicates a higher risk of stroke. It is not known whether investigating and treating blood pressure, blood cholesterol, or similar risk factors after a first seizure is an effective way to prevent stroke. A traditional clinical study would need too many patients and it would be unethical not to treat the control group. We have designed a study in which participating neurology departments change their practice to test and treat vascular risk factors. Patients are then compared to historic controls using registered data.
越来越多的证据表明，迟发性发作的患者发生中风的风险增加，但通过危险因素筛查和管理降低心血管发病率的潜力尚不清楚。我们旨在确定中年后新发无诱因癫痫发作的个体是否应进行血管风险评估。评估中风风险需要长期随访，而血管危险因素改变的已知益处使得标准 RCT 在实践和伦理上具有挑战性。相反，我们提出并制定了一项集群项目方案，以评估在干预试验中进行血管危险因素筛查的效果，以及一项队列研究。
参与的神经科诊所将把标准心血管危险因素评估纳入≥50 岁个体的常规评估中，这些个体在无诱因癫痫发作后首次接受专科咨询，但不包括进行性脑疾病患者。该项目有两个相互关联的部分：一项前瞻性单组试验，其中进行危险因素评估，并对随后的管理进行为期一年的随访；以及一项基于登记的队列研究，通过比较研究开始后两年内首次就诊的患者与同一诊所前四年就诊的患者，在系统层面上检查干预的长期效果。
干预试验的主要结局是接受后续药物治疗的患者比例。队列研究的主要结局是瑞典中风登记处的急性中风发生率。
获得资金时将寻求瑞典伦理审查局的批准（仅有效 2 年）。结果将通过同行评审的科学出版物传播。
该研究将在 clinicaltrials.gov 上注册。
中年或老年患者的首次癫痫发作表明中风风险较高。目前尚不清楚在首次癫痫发作后调查和治疗血压、血液胆固醇或类似危险因素是否是预防中风的有效方法。传统的临床研究需要太多的患者，而且不治疗对照组在伦理上是不可接受的。我们设计了一项研究，参与的神经科部门改变他们的实践来测试和治疗血管危险因素。然后，使用登记数据将患者与历史对照进行比较。
