Risk Prediction in Type II Diabetics With Ischemic Heart Disease
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
Type-2 Diabetes Mellitus
Ischemic Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function|
- Major cardiovascular event [ Time Frame: 2 years ] [ Designated as safety issue: No ]Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke
- Cardiovascular mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- sudden cardiac death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Total mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2016|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422057
|Contact: Christine Zürn, MD||+49 7071 29 firstname.lastname@example.org|
|Department of Cardiology||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Christine Zürn, MD +49 7071 29 83153 email@example.com|
|Principal Investigator: Axel Bauer, MD|