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Cardiovascular risk factor assessment in late-onset seizures: A study protocol to assess the value of structured
David Larsson1,2,3, Signild Åsberg4, Johan Sundström4,5
1Department of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Insights
A first seizure in older adults signals increased stroke risk. This study investigates if managing vascular risk factors after a seizure effectively prevents strokes, using a novel clinical trial and cohort design.
Area of Science:
- Neurology
- Cardiovascular Medicine
- Epidemiology
Background:
- Late-onset seizures are associated with a higher risk of stroke.
- The efficacy of managing vascular risk factors in this population remains unestablished.
- Traditional randomized controlled trials (RCTs) present ethical and logistical challenges for stroke prevention studies.
Purpose of the Study:
- To evaluate the effectiveness of vascular risk factor screening and management in individuals aged 50 years and older following a new-onset unprovoked seizure.
- To determine if proactive cardiovascular risk factor intervention can reduce stroke incidence in this patient group.
Main Methods:
- A cluster project involving neurology clinics implementing standard cardiovascular risk factor assessment for new-onset unprovoked seizures in patients aged 50+.
- Two components: a one-year prospective single-group trial monitoring risk factor management and a register-based cohort study comparing recent patients with historical controls.
- Primary outcomes include pharmacological treatment uptake (intervention trial) and acute stroke incidence (cohort study) from the Swedish Stroke Register.
Main Results:
- The primary outcome for the intervention trial is the proportion of patients receiving subsequent pharmacological treatment.
- The primary outcome for the cohort study is the incidence of acute stroke in the Swedish Stroke Register.
- Long-term effects will be assessed by comparing patient cohorts.
Conclusions:
- A first seizure in middle-aged or older individuals is a significant indicator of elevated stroke risk.
- The study proposes a pragmatic approach to assess the impact of vascular risk factor management post-seizure.
- Utilizing a cluster design and registry data offers a feasible alternative to traditional RCTs for evaluating stroke prevention strategies.
Objective:
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.
Methods:
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.
Analysis:
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.
Ethics And Dissemination:
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.
Registration Details:
The study will be registered at clinicaltrials.gov.
Plain Language Summary:
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.
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