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NCT01422057 Clinical Trial

Risk Prediction in Type II Diabetics With Ischemic Heart Disease

Ischemic Heart Disease Clinical Trial

Official title:
Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01422057
Other study ID # 402/2009BO2-2
Secondary ID
Status Recruiting
Phase N/A
First received August 9, 2011
Last updated February 5, 2014
Start date January 2010
Est. completion date January 2016

Study information
Verified date February 2014
Source Thebiosignals.com
Contact Christine Zürn, MD
Phone +49 7071 29 83153
Email christine.zuern@med.uni-tuebingen.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 2016
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Cardiology Tübingen

Sponsors (1)
Lead Sponsor Collaborator
Thebiosignals.com

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major cardiovascular event Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke 2 years No
Secondary Cardiovascular mortality 2 years No
Secondary sudden cardiac death 2 years No
Secondary Total mortality 2 years No
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