Trial document




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  DRKS00004919

Trial Description

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Title

Transthoracic echocardiography in ACS patients in the pre-hospital emergency

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Trial Acronym

TTE_Emergency

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This is a scientific study, in which is to be examined whether already at the emergency is past and find out with greater safety by early ultrasound examination at heart, which on the one hand are the cause of the symptoms and on the other with the presumptive diagnosis of acute coronary syndrome (Narrowed coronary arteries ) leads to faster treatment of the opening of the throat. There are two study groups, one gets the standard method and the other group will receive the early ultrasound diagnosis.

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Brief Summary in Scientific Language

Can a transthoracic echocardiography (TTE), which is already performed by the emergency physician in preclinical patients with NSTEMI ACS and a regional wall motion disorder diagnosed?
Leads in patients with NSTEMI, where preclinical regional wall motion disorder is diagnosed in a shortening of the contact-to-balloon time.
Comparison standard method NSTEMI vs. TTE preclinical and in the presence of regional wall motion abnormalities transport to the cardiac catheterization

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Organizational Data

  •   DRKS00004919
  •   2013/04/29
  •   [---]*
  •   yes
  •   Approved
  •   9/2/13, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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

  •   myocardial infarction
  •   I20 -  Angina pectoris
  •   I21 -  Acute myocardial infarction
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Interventions/Observational Groups

  •   Presence of ACS (acute coronary syndrom): Standard procedure for NSTEMI (Non-ST-elevation myocardial infarction) > Transportation Emergency / CPU
  •   Presence of ACS (acute coronary syndrom) : Transthoracic echocardiography in NSTEMI (Non-ST-elevation myocardial infarction) patients> If there regional wall motion abnormalities> Transportation to the cardiac catheterization
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- Compliance of identified wall motion abnormalities with ischemic area in the cardiac catheterization findings
- Contact-to-balloon time with NSTEMI (Non-ST-elevation myocardial infarction)

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Secondary Outcome

- Incidence of NSTEMI ACS patients
- Pre-clinically feasible echocardiography (examination quality)
- Incidence of wall motion abnormalities in ACS patients
- Incidence of other diseases diagnosed by TTE (transthoracic Echocardiography) (pleural effusion, pulmonary embolism, aortic stenosis / insufficiency, pericardial effusion)
- 30 and 90 days in-hospital-mortality
- Hospital days, ICU days, and monitor surveillance

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/08/01
  •   100
  •   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

Be included adult patients (≥ 18 years) treated by the emergency physician at ACS. Planned are 100 patients, with 50 patients in the standard procedure, and 50 patients in cardiac echo examination study group

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Exclusion Criteria

Exclusion criteria are:
- Lack of patient consent
- A history of heart attack
- = Known heart failure = / > NYHA III
- Previously described wall motion abnormalities in cardiac echo (post hoc exclusion)

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Addresses

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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Abteilung Kardiologie und Pneumologie
    • Mr.  Prof. Dr.  Gerd  Hasenfuß 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
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    •   0551 - 390
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen Zentrum Anästhesiologie, Rettungs- und Intensivmedizin
    • Mr.  Dr. med.  Ingo  Bergmann 
    • Robert-Koch STr. 40
    • 37075  Göttingen
    • Germany
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Status

  •   Recruiting planned
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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.