About this trial
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.
The investigators aim to determine whether individuals with new-onset unprovoked seizures after middle age should undergo vascular risk assessment. In a cluster project the investigators assess the effect of vascular risk factor screening in an observational study as well as a cohort study.
The project has two interlinked components: a prospective single group study, 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥50 with a first-ever outpatient appointment to one of the participating clinics and
a first-listed diagnostic code for seizures or epilepsy (ICD-10: R568, G40)
Disqualifiers
Inability to consent.
Progressive brain disease (tumour or degenerative)
preexisting seizures/epilepsy, as demonstrated by a registered diagnostic code for seizures (ICD-10: R568, G40, G41) or a dispensed antiseizure medication (ATC-code: N03) more than 3 months before the initial consultation
a registered diagnostic code for stroke or TIA (ICD-10: I61, I63, I64, or G45 except G454) before the initial consultation, or
Trial population
Patients aged ≥50 with a first-ever outpatient appointment for seizures or epilepsy to one of the participating clinics.
Trial design
Other
Prospective
Treatments tested in this trial
Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)
Other interventionThe vascular risk assessment is outlined below, there may be slight variations according to local routines. Overall, the screening should include: Family history of vascular disease Tests/examinations (order or obtain from medical records \[past 3 months\]) Weight Height Waist circumference 12-lead ECG Resting and standing blood pressure Total cholesterol HDL cholesterol LDL cholesterol HbA1c High sensitivity CRP Serum creatinine Urine albumin-to-creatinine ratio Medical history Atherosclerotic cardiovascular disease Atrial fibrillation Congestive heart failure Diabetes mellitus Hypertension Kidney disease Life-style risk factors (smoking, exercis
Treatment groups
Trial outcomes
Primary outcomes
Proportion with pharmacological intervention
The proportion with pharmacological intervention of modifiable vascular risk factors.
Secondary outcomes
Secondary outcomes in prospective clinical study
Proportion (%) with hypertension, diabetes mellitus, moderate to severe chronic kidney disease, atrial fibrillation.
Secondary outcomes at 1 year follow-up prospective clinical study
Delta (absolute and %) in modifiable vascular risk factors compared to baseline, changes in SCORE2/SCORE2-OP, adverse effects, arrhythmias, retention of pharmacological intervention.
Other outcomes
Register study outcomes
The primary outcome is a registered acute stroke, measured with yearly extractions from the Swedish national stroke register (95% coverage of acute strokes in Sweden). Secondary outcomes: cardiovascular events, a composite measure of the variables stroke (primary outcome), myocardial infarction (ICD-10 I21-I22 in NPR or death from myocardial infarction in the CDR), and cardiovascular death (an ICD-10 code of I0-I99 \[diseases of the circulatory system\] as the underlying cause of death). Other secondary outcomes include all-cause mortality, stroke severity (NIHSS at stroke admission; modified Rankin Scale 3 months post-stroke), arrythmias or conduction disorder (relevant ICD-10/procedure codes suggestive of conduction disorder, arrhythmia or cardiac arrest), and occurrence of recurrent seizures, captured by the NPR (hospital admissions \[inpatient care\] or emergency room visits with a seizure-related diagnostic code \[ICD-10: R56.8, G40, or G41\] as the first-listed diagnosis).
Sponsors and contacts
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Sahlgrenska University Hospital
Lead sponsor
Sodra Alvsborgs Hospital
Collaborator
Skane University Hospital
Collaborator
Danderyd Hospital
Collaborator
Uppsala University Hospital
Collaborator