Risk Prediction in Type II Diabetics With Ischemic Heart Disease

This study is currently recruiting participants.

Verified August 2011 by Thebiosignals.com

Sponsor:

Information provided by (Responsible Party):

Axel Bauer, Thebiosignals.com

ClinicalTrials.gov Identifier:

NCT01422057

First received: August 9, 2011

Last updated: August 22, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

August 9, 2011

Last Updated Date

August 22, 2011

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Major cardiovascular event [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01422057 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Risk Prediction in Type II Diabetics With Ischemic Heart Disease

Official Title ^ICMJE

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

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).

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Type-2 Diabetes Mellitus
Ischemic Heart Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Christine Zürn, MD

+49 7071 29 83153

christine.zuern@med.uni-tuebingen.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01422057

Other Study ID Numbers ^ICMJE

402/2009BO2-2

Has Data Monitoring Committee

Responsible Party

Axel Bauer, Thebiosignals.com

Study Sponsor ^ICMJE

Thebiosignals.com

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Thebiosignals.com

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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