Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests).
- Who it may be relevant to
- Registry conditions: Epilepsy, Seizure. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Cluster design: Participating sites start with vascular risk factor intervention - patients are then offered participation in an observational 1-year study. In addition, all patients at the sites are followed in registers and compared to historic controls. Follow-up in the register study will be at least 5, but probably 10 years (until significant difference in primary analysis - Kaplan Meier).
Interventions
- Other Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)
The 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 Atherosclerot
Primary outcome measures
- Proportion with pharmacological intervention [Time frame: 1 year]
Secondary outcome measures (2)
- Secondary outcomes in prospective clinical study [Time frame: At recruitment]
- Secondary outcomes at 1 year follow-up prospective clinical study [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
Clinical study:
\- First assessment for unprovoked seizures or epilepsy with onset after age 50 -- - vascular risk factor evaluation per the new routine at participating care givers
Register study:
- 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)
Exclusion criteria
Clinical study:
- Inability to consent.
- Progressive brain disease (tumour or degenerative)
Register study:
- 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
- progressive brain disease, as indicated by diagnostic codes or drug prescriptions suggestive of brain tumors (ICD-10: C71, D33, D43, C793) or
- neurocognitive disorders (ICD-10: F00-F03, F051, G30, G318, G912; ATC code: N06D).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Sweden · 3 centers
- Södra Älvsborg Sjukhus — Borås
- Salgrenska University Hospital — Gothenburg
- Skånes universitetssjukhus — Malmö
Publications
- Larsson D, Asberg S, Sundstrom J, Frid P, Zelano J. Cardiovascular risk factor assessment in late-onset seizures: A study protocol to assess the value of structured intervention. Epilepsia Open. 2024 Aug;9(4):1611-1617. doi: 10.1002/epi4.12987. Epub 2024 Jun 14. PMID 38874366
Identifiers
NCT: NCT07116330 · 2024-08662