Risk Prediction in Type II Diabetics With Ischemic Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Thebiosignals.com
Sponsor:
Information provided by (Responsible Party):
Axel Bauer, Thebiosignals.com
ClinicalTrials.gov Identifier:
NCT01422057
First received: August 9, 2011
Last updated: February 5, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Thebiosignals.com:

Primary Outcome Measures:
  • Major cardiovascular event [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke


Secondary Outcome Measures:
  • 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 2016
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422057

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

Locations
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         
Sponsors and Collaborators
Thebiosignals.com
  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: February 5, 2014
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 September 14, 2014