Mi-RNAs and Specificity of Hs-TnT in Symptomatic ED Patients
Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED
1 other identifier
observational
N/A
0 countries
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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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 16, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedApril 16, 2014
April 1, 2014
1.5 years
April 14, 2014
April 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
90 days
Secondary Outcomes (1)
Myocardial Infraction
90 days
Eligibility Criteria
Patients presenting to the emergency department with symptoms suggestive of acute coronary syndrome.
You may qualify if:
- 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
You may not qualify if:
- Mental disorders, dementia
- Pregnancy, breast feeding
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Biener M, Giannitsis E, Thum T, Bar C, Costa A, Andrzejewski T, Stoyanov KM, Vafaie M, Meder B, Katus HA, de Gonzalo-Calvo D, Mueller-Hennessen M. Diagnostic value of circulating microRNAs compared to high-sensitivity troponin T for the detection of non-ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):653-660. doi: 10.1093/ehjacc/zuaa034.
PMID: 33580779DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evangelos Giannitsis, MD
University Hospital Heidelberg
- STUDY DIRECTOR
Hugo A Katus, MD
University Hospital Heidelberg
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Cardiology
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 16, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Last Updated
April 16, 2014
Record last verified: 2014-04