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

NCT ID: NCT02116153

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Myocardial Infarction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Stiftung für Herzforschung

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Professor Hugo Katus

Director, Department of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evangelos Giannitsis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Hugo A Katus, MD

Role: STUDY_DIRECTOR

University Hospital Heidelberg

Central Contacts

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Moritz Biener, MD

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 33580779 (View on PubMed)

Other Identifiers

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UHHD-BM-003

Identifier Type: -

Identifier Source: org_study_id

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