Risk Prediction in Type II Diabetics With Ischemic Heart Disease
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Purpose
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
| Condition |
|---|
|
Type-2 Diabetes Mellitus Ischemic Heart Disease |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2012 (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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.
Inclusion Criteria:
- type-2 diabetes
- coronary artery disease
Exclusion Criteria:
- age >80 years
- acute coronary syndrome
- life expectancy <1 year
- unable to give informed consent
Contacts and Locations| Contact: Christine Zürn, MD | +49 7071 29 83153 | christine.zuern@med.uni-tuebingen.de |
| Germany | |
| Department of Cardiology | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Christine Zürn, MD +49 7071 29 83153 christine.zuern@med.uni-tuebingen.de | |
| Principal Investigator: Axel Bauer, MD | |
More Information
No publications provided
| Responsible Party: | Axel Bauer, Prof. Dr. med. Axel Bauer, Thebiosignals.com |
| ClinicalTrials.gov Identifier: | NCT01422057 History of Changes |
| Other Study ID Numbers: | 402/2009BO2-2 |
| Study First Received: | August 9, 2011 |
| Last Updated: | August 22, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Thebiosignals.com:
|
diabetes coronary artery disease ischemic heart disease autonomic function |
heart rate turbulence deceleration capacity severe autonomic failure |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Diabetes Mellitus Diabetes Mellitus, Type 2 Heart Diseases Ischemia Coronary Disease Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013