Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 3
- 主要终点
- Proportion with pharmacological intervention
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
First seizure after age 50
All patients evaluated for a first seizure after age 50 at the providers.
干预措施: Vascuar risk factor screening (blood pressure, medical history, BMI, laboratory tests) (Other)
结局指标
主要结局
Proportion with pharmacological intervention
时间窗: 1 year
The proportion with pharmacological intervention of modifiable vascular risk factors.
次要结局
- Secondary outcomes in prospective clinical study(At recruitment)
- Secondary outcomes at 1 year follow-up prospective clinical study(1 year)
研究者
Johan Zelano
Professor
Sahlgrenska University Hospital