Risk Prediction in Type II Diabetics With Ischemic Heart Disease
- Conditions
- Type-2 Diabetes MellitusIschemic Heart Disease
- Registration Number
- NCT01422057
- Lead Sponsor
- Thebiosignals.com
- Brief Summary
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
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- type-2 diabetes
- coronary artery disease
- age >80 years
- acute coronary syndrome
- life expectancy <1 year
- unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major cardiovascular event 2 years Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke
- Secondary Outcome Measures
Name Time Method Cardiovascular mortality 2 years sudden cardiac death 2 years Total mortality 2 years
Trial Locations
- Locations (1)
Department of Cardiology
🇩🇪Tübingen, Germany