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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2035-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Epilepsy Seizure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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First seizure after age 50

All patients evaluated for a first seizure after age 50 at the providers.

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

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No