Risk Prediction in Type II Diabetics With Ischemic Heart Disease
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|ClinicalTrials.gov Identifier: NCT01422057|
Recruitment Status : Unknown
Verified February 2014 by Axel Bauer, Thebiosignals.com.
Recruitment status was: Recruiting
First Posted : August 23, 2011
Last Update Posted : February 6, 2014
|Condition or disease|
|Type-2 Diabetes Mellitus Ischemic Heart Disease|
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|
|Estimated Enrollment :||500 participants|
|Official Title:||Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2016|
- Major cardiovascular event [ Time Frame: 2 years ]Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke
- Cardiovascular mortality [ Time Frame: 2 years ]
- sudden cardiac death [ Time Frame: 2 years ]
- Total mortality [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422057
|Contact: Christine Zürn, MD||+49 7071 29 firstname.lastname@example.org|
|Department of Cardiology||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Christine Zürn, MD +49 7071 29 83153 email@example.com|
|Principal Investigator: Axel Bauer, MD|