Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07116330

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizure Seizures Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Södra Älvsborg Sjukhus, Borås, Sweden

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests)

Other

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

Primary outcomes

  1. Proportion with pharmacological intervention

    Time frame: 1 year

    The proportion with pharmacological intervention of modifiable vascular risk factors.

Secondary outcomes

  1. Secondary outcomes in prospective clinical study

    Time frame: At recruitment

    Proportion (%) with hypertension, diabetes mellitus, moderate to severe chronic kidney disease, atrial fibrillation.

  2. Secondary outcomes at 1 year follow-up prospective clinical study

    Time frame: 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.

Other outcomes

  1. Register study outcomes

    Time frame: 5-10 years

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

David Larson, MD PhD

CONTACT

[email protected]

+46313421000

Johan Zelano, MD PhD

CONTACT

[email protected]

+46313421000

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Danderyd Hospital
  • Skane University Hospital
  • Sodra Alvsborgs Hospital
  • Uppsala University Hospital

Registry information

Acronym: LOSTIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2035
First posted
Aug 11, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.