Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Major cardiovascular event
研究概览
简要总结
The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease
详细描述
In patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected.
In the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from Holter recordings and 30-minute recordings of high-resolution three dimensional ECG, non-invasive arterial blood pressure and respiratory activity.
The correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. Autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). Assessment of severity of diabetes includes levels of HbA1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type-2 diabetes
- •coronary artery disease
排除标准
- •age >80 years
- •acute coronary syndrome
- •life expectancy <1 year
- •unable to give informed consent
结局指标
主要结局
Major cardiovascular event
时间窗: 2 years
Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke
次要结局
- Cardiovascular mortality(2 years)
- sudden cardiac death(2 years)
- Total mortality(2 years)
研究者
Axel Bauer
Prof. Dr. med. Axel Bauer
Thebiosignals.com