Risk Prediction in Type II Diabetics With Ischemic Heart Disease

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01422057

Enrollment

500

Registered

2011-08-23

Start date

2010-01-31

Completion date

2016-01-31

Last updated

2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease, Type-2 Diabetes Mellitus

Keywords

diabetes, coronary artery disease, ischemic heart disease, autonomic function, heart rate turbulence, deceleration capacity, severe autonomic failure

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Major cardiovascular event	2 years	Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke

Secondary

Measure	Time frame
Cardiovascular mortality	2 years
sudden cardiac death	2 years
Total mortality	2 years

Countries

Germany

Contacts

Primary ContactChristine Zürn, MD

christine.zuern@med.uni-tuebingen.de+49 7071 29 83153

Outcome results