Risk Prediction in Type II Diabetics With Ischemic Heart Disease

NCT ID: NCT01422057

Last Updated: 2014-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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).

Conditions

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Type-2 Diabetes Mellitus Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thebiosignals.com

OTHER

Sponsor Role lead

Responsible Party

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Axel Bauer

Prof. Dr. med. Axel Bauer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology

Tübingen, Tübingen, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christine Zürn, MD

Role: CONTACT

+49 7071 29 83153

Facility Contacts

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Christine Zürn, MD

Role: primary

+49 7071 29 83153

Other Identifiers

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402/2009BO2-2

Identifier Type: -

Identifier Source: org_study_id

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