Risk Prediction in Type II Diabetics With Ischemic Heart Disease
NCT ID: NCT01422057
Last Updated: 2014-02-06
Study Results
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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UNKNOWN
500 participants
OBSERVATIONAL
2010-01-31
2016-01-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* coronary artery disease
Exclusion Criteria
* acute coronary syndrome
* life expectancy \<1 year
* unable to give informed consent
18 Years
80 Years
ALL
No
Sponsors
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Thebiosignals.com
OTHER
Responsible Party
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Axel Bauer
Prof. Dr. med. Axel Bauer
Locations
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Department of Cardiology
Tübingen, Tübingen, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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402/2009BO2-2
Identifier Type: -
Identifier Source: org_study_id
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