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Mi-RNAs and Specificity of Hs-TnT in Symptomatic ED Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02116153
Recruitment Status : Unknown
Verified April 2014 by Professor Hugo Katus, University Hospital Heidelberg.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Deutsche Stiftung für Herzforschung
Information provided by (Responsible Party):
Professor Hugo Katus, University Hospital Heidelberg

Brief Summary:
Biomarkers play a key role in the diagnostic workup of patients presenting to an emergency department (ED). European and American guidelines recommend cardiac Troponin (T or I) as the biomarker gold standard for the diagnosis of non-ST-elevation myocardial infarction (non-STEMI). Today, high-sensitivitiy assays are available and allow an early diagnosis of non-STEMI and the detection of troponin in individuals that would have been classified as unstable angina with former assays. As many patients are detected with elevated troponin values with the high sensitivity assays, specificity for non-STEMI has inevitably decreased. Micro-RNAs (mi-RNA) are new biomarkers with a wide spectrum of detectable conditions that allow specific identification of myocardial infarction. The aim of this study is to develop a biomarker protocol that combines the high sensitivity of cardiac Troponin T and the high specificity of mi-RNA profiles for early and safe identification of non-STEMI in ED patients.

Condition or disease
Coronary Artery Disease Myocardial Infarction

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Study Type : Observational
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED
Study Start Date : June 2014
Estimated Primary Completion Date : December 2015

Primary Outcome Measures :
  1. Death [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Myocardial Infraction [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the emergency department with symptoms suggestive of acute coronary syndrome.

Inclusion Criteria:

  • Patients admitted to the emergency department ("chest pain unit"), Dept. of Cardiology, University Hospital Heidelberg
  • Symptoms suggestive of ACS incl. chest pain, dyspnea, atypical pain
  • Age >= 18 years
  • Written informed consent

Exclusion Criteria:

  • Mental disorders, dementia
  • Pregnancy, breast feeding
  • Age < 18 years

Information from the National Library of Medicine

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 identifier (NCT number): NCT02116153

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Contact: Moritz Biener, MD

Sponsors and Collaborators
University Hospital Heidelberg
Deutsche Stiftung für Herzforschung
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Principal Investigator: Evangelos Giannitsis, MD University Hospital Heidelberg
Study Director: Hugo A Katus, MD University Hospital Heidelberg
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Hugo Katus, Director, Department of Cardiology, University Hospital Heidelberg Identifier: NCT02116153    
Other Study ID Numbers: UHHD-BM-003
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Keywords provided by Professor Hugo Katus, University Hospital Heidelberg:
Cardiac Troponin T
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases