NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,062
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60 years. Patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol.
Parents of patients and partners are invited to return their answers of standardized questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction or peripheral artery disease.
Study inclusion time of patients and their families is 5 years. A biobank is build from samples from patients, partners and adult children. Clinical follow-ups for patients and partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are planned after 10 and 20 years.
Hypotheses:
What do patients know about their parents clinical ischemic events? How much established pathology in arteries do we find by a standardized ultrasound protocol at the time of ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings between patients and partners? Differences between children from families with several ischemic events among parents and grandparents vs. children from families without ischemic events? Biochemical markers related to ultrasound findings and artery disease.
详细描述
Equal examinations for patients, partners and adult children are:
- Standardized questionnaires
- Extracranial duplexsonography
- Duplexsonography of the abdominal aorta
- Duplexsonography of femoral arteries
- Duplexsonography of epicardial, intrabdominal and subcutaneous fat
- Peripheral ultrasound, Ankle-arm index
- ECG
- Blood pressure measurement
- BMI and Waist-hip ratio
- Blood samples
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented ischemic stroke at age from 15 up to 60 years
排除标准
- •Stroke as end-of-life event among patients with cancer or other life-threatening disease
- •Stroke caused by trauma
研究组 & 干预措施
Lifestyle counseling
There are no different arms, NOR-SYS is an observational study
干预措施: Lifestyle counseling (Behavioral)
结局指标
主要结局
All cause mortality
时间窗: 15 years for patients and partners and 20 years for offspring
Outcome measure is assessed every five years.
次要结局
- Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease(15 years for patients and partners and 20 years for offspring)