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

February 27, 2026 updated by: Johan Zelano, Sahlgrenska University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥50 with a first-ever outpatient appointment for seizures or epilepsy to one of the participating clinics.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First seizure after age 50
All patients evaluated for a first seizure after age 50 at the providers.
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 Atherosclerotic cardiovascular disease Atrial fibrillation Congestive heart failure Diabetes mellitus Hypertension Kidney disease Life-style risk factors (smoking, exercis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes in prospective clinical study
Time Frame: At recruitment
Proportion (%) with hypertension, diabetes mellitus, moderate to severe chronic kidney disease, atrial fibrillation.
At recruitment
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.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital

Collaborators

Danderyd Hospital
Skane University Hospital
Uppsala University Hospital
Sodra Alvsborgs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2035

Study Registration Dates

First Submitted

June 10, 2025

First Submitted That Met QC Criteria

August 8, 2025

First Posted (Actual)

August 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-08662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Privacy laws and regulations prevent most sharing of data. Anonymized or processed data may be shared upon reasonable request if regulatory possibilities allow.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe