Risk Prediction in Type II Diabetics With Ischemic Heart Disease

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

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

Study Overview

• Status: Unknown
• Conditions: Ischemic Heart Disease; Type-2 Diabetes Mellitus

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
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Christine Zürn, MD; Phone Number: +49 7071 29 83153; Email: christine.zuern@med.uni-tuebingen.de

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • Department of cardiology
    • Contact: Christine Zürn, MD; Phone Number: +49 7071 29 83153; Email: christine.zuern@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Total mortality	2 years
Cardiovascular mortality	2 years
sudden cardiac death	2 years

Collaborators and Investigators

• Sponsor: Thebiosignals.com

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimate): August 23, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2014
• Last Update Submitted That Met QC Criteria: February 5, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: diabetes; ischemic heart disease; coronary artery disease; autonomic function; heart rate turbulence; deceleration capacity; severe autonomic failure
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2; Ischemia
• Other Study ID Numbers: 402/2009BO2-2