The Berlin 'Cream&Sugar' Study: the Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 573
- 试验地点
- 1
- 主要终点
- Recurrent Stroke
研究概览
简要总结
Non-fasting triglyceride levels are thought to play a role in stroke. The investigators hypothesise that the results of a standardised oral triglyceride tolerance test in the subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of recurrent stroke within 12 months after the index event.
详细描述
Since high postprandial triglycerides levels may be a risk factor for stroke, we use a combined oral triglyceride and glucose tolerance test in patients who had a first ischemic stroke. Follow-up after one year primarily assesses wether or not a recurrent stroke has occured. The glucose tolerance test is meant to identify patients with metabolic syndrome (and diabetes), since this condition is per se associated with increased levels of triglycerides. Potentially, the post-challenge triglyceride levels only play a role in patients without diabetes or metabolic syndrome. For further details see Ebinger et al. 'The Berlin 'Cream&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke', IJS; 2010,5, 47-51.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •First ischemic stroke
- •Incidence within less than 7 days
- •Informed consent obtained
排除标准
- •Aphasia (if hampering informed consent)
- •Swallowing disorder
- •Pregnancy
- •Renal or hepatic failure
- •Pancreatitis
- •Cholecystolithiasis
- •Malabsorption
- •Lactose intolerance
- •Psychosis
- •Drug and/or alcohol addiction
- •Expected life expectancyr12 months
- •Inability to sign informed consent
- •Acute coronary syndrome
- •Severe heart valve disorder
- •Heart failure (NYHA III-IV)
- •Severe infectious/rheumatic disease
- •Sever metabolic disease
- •No oral glucose tolerance test in case of known diabetes
结局指标
主要结局
Recurrent Stroke
时间窗: outcome measure is assessed one year after first ischemic stroke.
The primary end-point of the study is a recurrent fatal or nonfatal stroke within the first 12 months after the event.
次要结局
- MI(one year after first ischemic stroke)
- death(one year after first ischemic stroke)
- TIA(one year after first ischemic stroke)
研究者
Martin Ebinger
PD Dr. med. Dr. phil.
Charite University, Berlin, Germany