Trial document




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  DRKS00007700

Trial Description

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Title

Cardiovascular stress testing and high-sensitivity cardiac troponin for diagnosing obstructive coronary heart disease

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Cardiovascular stresstesting such as stress echocardiography (sonography of the heart combined with exercise) is the guideline recommended method for evaluation of patients with suspected coronary obstruction. However, similar as many tests there are certain limitations that might lead to unnecessary invasive tested triggered by false positive test results. Cardiac troponin, a heart specific protein that can be detected in blood, is associated with the extend of coronary heart disease.
Aim of this non-intenventional, retrospective analysis is to evaluate the test performance of stress echocardiography for detection of an obstructive coronary heart disease in patients undergoing elective coronary intervention following stress testing, and if the additional use of cardiac troponin can improve the diagnostic accuracy of stress testing.

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Brief Summary in Scientific Language

Cardiovascular stresstesting by stress echocardiography and other tests has certain limitations such as limited sensitivity. Cardiac troponin is associated with the extend of coronary heart disease. Therefore, it can be expected that cardiac troponin tested at rest might improve the test performance of stress echocardiography for detection of an obstructive coronary heart disease.
Aim of this non-intenventional, retrospective analysis is to evaluate the test performance of stress echocardiography for detection of an obstructive coronary heart disease in patients undergoing elective coronary intervention following stress testing, and if the additional use of cardiac troponin can improve the diagnostic accuracy of stress testing.

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Organizational Data

  •   DRKS00007700
  •   2015/01/15
  •   [---]*
  •   yes
  •   Approved
  •   594/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   I25 -  Chronic ischaemic heart disease
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Interventions/Observational Groups

  •   Patients undergoing elective coronary angiography following stress echocardiography and testing of high-sensitivity troponin T
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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 obstructive coronary heart disease

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Secondary Outcome

indication for coronary revascularization

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/01/31
  •   2000
  •   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

- age >= 18 years
- stress echocardiography performed before coronary angiography
- coronary angiography within 60 days following stress echocardiography
- testing of high-sensitivity cardiac troponin T withing 3 days before coronary angiography (and before or at leat 24 hours following stress echocardiography)

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Exclusion Criteria

acute myocardial infarction

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Herzzentrum Freiburg Bad KrozingenKlinik für Kardiologie und Angiologie II
    • Mr.  PD Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg Bad KrozingenKlinik für Kardiologie und Angiologie II
    • Mr.  PD Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Universitäts-Herzzentrum Freiburg Bad KrozingenKlinik für Kardiologie und Angiologie II
    • Mr.  PD 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 KrozingenKlinik für Kardiologie und Angiologie II
    • Mr.  PD Dr. med.  Willibald  Hochholzer 
    • Südring 15
    • 79189  Bad Krozingen
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.