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Risk Prediction in Type II Diabetics With Ischemic Heart Disease

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ClinicalTrials.gov Identifier: NCT01422057
Recruitment Status : Unknown
Verified February 2014 by Axel Bauer, Thebiosignals.com.
Recruitment status was:  Recruiting
First Posted : August 23, 2011
Last Update Posted : February 6, 2014
Information provided by (Responsible Party):
Axel Bauer, 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

Condition or disease
Type-2 Diabetes Mellitus 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).

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function
Study Start Date : January 2010
Primary Completion Date : January 2014
Estimated Study Completion Date : January 2016

Primary Outcome Measures :
  1. Major cardiovascular event [ Time Frame: 2 years ]
    Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke

Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 2 years ]
  2. sudden cardiac death [ Time Frame: 2 years ]
  3. Total mortality [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422057

Contact: Christine Zürn, MD +49 7071 29 83153 christine.zuern@med.uni-tuebingen.de

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         
Sponsors and Collaborators

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
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Axel Bauer, Thebiosignals.com:
coronary artery disease
ischemic heart disease
autonomic function
heart rate turbulence
deceleration capacity
severe autonomic failure

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases