Secondary Prevention of Stroke Through Participation in the Non-drug Therapeutic Weight Reduction Program: A Single-blinded Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up.
研究概览
简要总结
SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. The therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. The primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. Secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ischemic stroke
- •Age: 20 - 85 years
- •BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm
- •Functional impairment, which would allow to participate in weight reduction program (mRS 0-4, NIHSS 0-12)
- •Patient must be capable of understanding informed consent
- •Written informed consent for participation in the study
排除标准
- •Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion)
- •Speech disturbance (aphasia or sever dysarthria)
- •Dimming of consciousness
- •Stroke due to arterial dissection or coagulation disorder
- •Drug-related weight changes during previous 3 months
- •Changes in appetite influencing medication listed in appendix during previous 3 months
- •Bariatric surgery in the past
- •Diabetes mellitus with a history of severe ketoacidosis
- •Pregnancy or nursing
- •Severe co-morbid disorders, e.g.:
- •AV-Block ≥ 2nd degree
- •Heart insufficiency (NYHA > 2)
- •Pericarditis, pericardial effusion
- •Severe kidney insufficiency (Creatinine > 3 mg/dl; Urea > 150 mg/dl)
- •Hepatic insufficiency (GOT > 3 x ULN; GPT > 3 x ULN)
- •Severe psychiatric disease within the last six months (psychosis, suicide attempts)
- •Chronic alcohol addiction or drug addiction
- •HIV- or hepatitis infection
- •Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to start of obesity program)
- •Cognitive impairment with MMSE < 20
- •Depression with BDI > 20
- •Patients who are unable to give consent to study participation (MMSE < 20, aphasia)
- •Recurrent stroke or myocardial infarction in the period between screening for study participation and start of weight reduction program
- •Simultaneous participation in another clinical trial
结局指标
主要结局
The primary endpoint is the number of deaths or major vascular events defined as stroke, TIA, myocardial infarction or hospitalization due to angina pectoris, which occur between the randomization and last follow-up.
时间窗: 18 months
次要结局
- Functional outcome(18 months)
- Cognitive deficits(18 months)
- Post stroke depression(18 months)
- Severity of arterial hypertension, diabetes mellitus and hyperlipidemia(18 months)
研究者
Dr. Yaroslav Winter
Neurologist and Research Fellow
Philipps University Marburg Medical Center