Risk Prediction in Type II Diabetics With Ischemic Heart Disease

Thebiosignals.com

Status: Unknown

Conditions: Ischemic Heart Disease; Type-2 Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT01422057

402/2009BO2-2

Details and patient eligibility

About

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

Full 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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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