Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
Recruiting · NCT07116330 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sahlgrenska University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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).
Where it is running
3 locations listed.
- Södra Älvsborg Sjukhus - Borås, Sweden
- Salgrenska University Hospital - Gothenburg, Sweden
- Skånes universitetssjukhus - Malmö, Sweden