Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sodra Alvsborgs Hospital | OTHER |
| Skane University Hospital | OTHER |
| Danderyd Hospital | OTHER |
| Uppsala University Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First seizure after age 50 | All patients evaluated for a first seizure after age 50 at the providers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion with pharmacological intervention | The proportion with pharmacological intervention of modifiable vascular risk factors. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes in prospective clinical study | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Register study outcomes | 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). |
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:
Exclusion Criteria
Clinical study:
Register study:
Not provided
Not provided
Not provided
Patients aged ≥50 with a first-ever outpatient appointment for seizures or epilepsy to one of the participating clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan Zelano, MD PhD | Contact | +46313421000 | johan.zelano@neuro.gu.se | |
| David Larson, MD PhD | Contact | +46313421000 | david.gw.larsson@vgregion.se |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södra Älvsborg Sjukhus | Recruiting | Borås | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38874366 | Background | 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. |
Not provided
Not provided
Privacy laws and regulations prevent most sharing of data. Anonymized or processed data may be shared upon reasonable request if regulatory possibilities allow.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D055991 | Health Records, Personal |
| D015992 | Body Mass Index |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
|
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 |
| 5-10 years |
| Salgrenska University Hospital | Recruiting | Gothenburg | Sweden |
|
| Skånes universitetssjukhus | Recruiting | Malmö | Sweden |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D000886 | Anthropometry |
| D010829 | Physiological Phenomena |
| D001699 | Biometry |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |