Trial document





This trial has been registered retrospectively.
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  DRKS00009713

Trial Description

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Title

Validation of the novel 1-hour rule-in and rule-out troponin algorithm for diagnosis of non-ST-elevation myocardial infarction of the European Society of Cardiology

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Cardiac specific biomarkers that can be detected in the blood and that indicate necrosis of heart muscle cells are a key feature needed for the diagnosis of myocardial infarction together with clinical symptoms and the electrocardiogram. One of these biomarkers is cardiac troponin.
Due to new developments in laboratory techniques, the sensitivity of troponin assays has significantly improved. This allows to detect the beginning of a myocardial infarction not only after 6 hours as with previous assays, but to detect a myocardial infarction already within 1 hour.
Thus, current guidelines recommend to test cardiac troponin on admission and 1 hour thereafter for diagnosis of myocardial infarction.

The aim of this prospective analysis is to validate a novel one hour troponin algorithm for diagnosis of myocardial infarction in clinical routine.

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Brief Summary in Scientific Language

The diagnosis of acute myocardial infarction is based on cardiac troponin as the central diagnostic criterium together with the clinical assessment, the electrocardiogram (ECG) and cardiac imaging studies. Evolution of cardiac troponin assays over the last years have markly improved sensitivity allowing now to detect very small changes in cardiac troponin levels.
This improvement in sensitivity made it possible to shorten the time between two troponin measurements, which are required for detection or exclusion of myocardial infarction.

The new 2015 Guidelines of the European Society of Cardiology for acute non-ST-elevation coronary syndromes recommend a one hour troponin diagnostic algorithm.

The aim of this prospective analysis is to validate the new one hour troponin diagnostic algorithm for diagnosis of myocardial infarction in clinical routine.

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Organizational Data

  •   DRKS00009713
  •   2015/12/07
  •   [---]*
  •   yes
  •   Approved
  •   499/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I21 -  Acute myocardial infarction
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Interventions/Observational Groups

  •   Patients presenting for rule-out of acute myocardial infarction by troponin testing at presentation and after one hour.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Diagnosis of acute myocardial infarction according to Universal Definition of Myocardial Infarction:
Detection of a rise and/or fall of cardiac biomarker values, (cardiac troponin) together with signs of ischaemia: clinical symptoms of ischaemia or new or presumed new significant ST-T wave changes or left bundle branch block on 12-lead ECG/development of pathological Q waves on ECG or imaging studies showing new or presumed new loss of viable myocardium or regional wall motion abnormality or intracoronary thrombus detected by angiography.

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Secondary Outcome

indication for coronary revascularization based on results of coronary angiography or clinical judgement.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/11/02
  •   1532
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients needing a rule-out of acute myocardial infarction due to:
- acute chest pain or other symptoms equivalent with acute chest pain within the last 24 hours
- new or presumably new ischaemic ECG changes
- new or presumably new signs of ischaemia in imaging studies
- available high-sensitivity cardiac troponin results at presentation and after 1 hour

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Exclusion Criteria

- missing troponin results after 1 hour
- chest pain lasting longer than 24 hours

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Herzzentrum Freiburg Bad Krozingen, Klinik für Kardiologie und Angiologie II
    • Mr.  Prof. Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg Bad Krozingen, Klinik für Kardiologie und Angiologie II
    • Mr.  Prof. Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg Bad Krozingen, Klinik für Kardiologie und Angiologie II
    • Mr.  Prof. Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-Herzzentrum Freiburg Bad Krozingen, Klinik für Kardiologie und Angiologie II
    • Mr.  Prof. Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/20
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.