Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07116330

Acronym

LOSTIT

Enrollment

420

Registered

2025-08-11

Start date

2025-09-01

Completion date

2035-06-01

Last updated

2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Seizure

Keywords

vascular risk, cardiovascular

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.

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

OTHERVascuar 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 Atherosclerotic cardiovascular disease Atrial fibrillation Congestive heart failure Diabetes mellitus Hypertension Kidney disease Life-style risk factors (smoking, exercis

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Proportion with pharmacological intervention	1 year	The proportion with pharmacological intervention of modifiable vascular risk factors.

Secondary

Measure	Time frame	Description
Secondary outcomes in prospective clinical study	At recruitment	Proportion (%) with hypertension, diabetes mellitus, moderate to severe chronic kidney disease, atrial fibrillation.
Secondary outcomes at 1 year follow-up prospective clinical study	1 year	Delta (absolute and %) in modifiable vascular risk factors compared to baseline, changes in SCORE2/SCORE2-OP, adverse effects, arrhythmias, retention of pharmacological intervention.

Countries

Sweden

Contacts

CONTACTJohan Zelano, MD PhD

johan.zelano@neuro.gu.se+46313421000

CONTACTDavid Larson, MD PhD

david.gw.larsson@vgregion.se+46313421000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026