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

Coronary Artery Disease Clinical Trial

Official title:

Clinical Use of Mi-RNAs to Improve Specificity of High-sensitivity Troponin T in Symptomatic Patients Presenting to the ED

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02116153
• Other study ID #: UHHD-BM-003
• Status: Not yet recruiting
• Phase: N/A
• First received: April 14, 2014
• Last updated: April 14, 2014
• Start date: June 2014

Study information

• Verified date: April 2014
• Source: University Hospital Heidelberg
• Contact: Moritz Biener, MD
• Email: moritz.biener[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Deutsche Stiftung für Herzforschung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		90 days	Yes
Secondary	Myocardial Infraction		90 days	Yes