Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
LOSTIT
1 other identifier
observational
420
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
August 11, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2035
March 3, 2026
February 1, 2026
2.2 years
June 10, 2025
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion with pharmacological intervention
The proportion with pharmacological intervention of modifiable vascular risk factors.
1 year
Secondary Outcomes (2)
Secondary outcomes in prospective clinical study
At recruitment
Secondary outcomes at 1 year follow-up prospective clinical study
1 year
Other Outcomes (1)
Register study outcomes
5-10 years
Study Arms (1)
First seizure after age 50
All patients evaluated for a first seizure after age 50 at the providers.
Interventions
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 Atherosclerotic cardiovascular disease Atrial fibrillation Congestive heart failure Diabetes mellitus Hypertension Kidney disease Life-style risk factors (smoking, exercis
Eligibility Criteria
Patients aged ≥50 with a first-ever outpatient appointment for seizures or epilepsy to one of the participating clinics.
You may qualify if:
- 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)
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sahlgrenska University Hospitallead
- Sodra Alvsborgs Hospitalcollaborator
- Skane University Hospitalcollaborator
- Danderyd Hospitalcollaborator
- Uppsala University Hospitalcollaborator
Study Sites (3)
Södra Älvsborg Sjukhus
Borås, Sweden
Salgrenska University Hospital
Gothenburg, Sweden
Skånes universitetssjukhus
Malmo, Sweden
Related Publications (1)
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: 38874366BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 10, 2025
First Posted
August 11, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2035
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Privacy laws and regulations prevent most sharing of data. Anonymized or processed data may be shared upon reasonable request if regulatory possibilities allow.