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Risk Prediction in Type II Diabetics With Ischemic Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by
Information provided by (Responsible Party):
Axel Bauer, Identifier:
First received: August 9, 2011
Last updated: February 5, 2014
Last verified: February 2014

August 9, 2011
February 5, 2014
January 2010
January 2014   (final data collection date for primary outcome measure)
Major cardiovascular event [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke
Same as current
Complete list of historical versions of study NCT01422057 on Archive Site
  • 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 ]
Same as current
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Risk Prediction in Type II Diabetics With Ischemic Heart Disease
Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function

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

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).

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.

  • Type-2 Diabetes Mellitus
  • Ischemic Heart Disease
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2016
January 2014   (final data collection date for primary outcome measure)

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
18 Years to 80 Years
Contact: Christine Zürn, MD +49 7071 29 83153
Axel Bauer,
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February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP