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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02116153
Enrollment
Unknown
Registered
2014-04-16
Start date
2014-06-30
Completion date
Unknown
Last updated
2014-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Infarction

Keywords

Cardiac Troponin T, Micro-RNA, Sensitivity, Specificity

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.

Interventions

None listed

Sponsors

Deutsche Stiftung für Herzforschung
CollaboratorOTHER
University Hospital Heidelberg
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Death90 days

Secondary

MeasureTime frame
Myocardial Infraction90 days

Contacts

Primary ContactMoritz Biener, MD
moritz.biener@med.uni-heidelberg.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026