Trial document




drksid header

  DRKS00005277

Trial Description

start of 1:1-Block title

Title

Mediators of post-infarct inflammation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is to assess different parameters that lead to inflammation after myocardial infarction. Controls with coronary artery disease and no infarction will be used as controls.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Patients after myocardial infarction often suffer from systemic inflammation. In this study blood parameters that lead to systemic inflammation in patients after acute myocardial infarction will be investigated. Results of this study will help to better understand post-infarct inflammation and will persumably allow to improve treatment after myocardial infarction.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005277
  •   2014/02/14
  •   [---]*
  •   yes
  •   Approved
  •   361/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I21 -  Acute myocardial infarction
  •   I25.9 -  Chronic ischaemic heart disease, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Inflammatory parameters of serum / plasma will be analyzed in infarct patients.
  •   Inflammatory serum / plasma parameters of patients with coronary artery disease without any signs for myocardial infarction will be assessed.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Differences in inflammatory parameters leading to increased c reactive protein (CRP) in infarct patients.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2014/02/15
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

acute myocardial infarction, stabile coronary artery disease, written informed consent, age >18 years.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

(hemato-) oncologic diseases, Hb < 9g/dl, age < 18years, no written informed consent.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • UHZ Freiburg - Bad KrozingenKardiologie & Angiologie I
    • Mr.  Prof. Dr. med.  Christoph  Bode 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsherzzentrum Freiburg - Bad KrozingenKardiologie & Angiologie I
    • Mr.  Dr.  Philipp  Diehl 
    • Hugstetterstr.55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsherzzentrum Freiburg - Bad KrozingenKardiologie & Angiologie I
    • Mr.  Dr.  Philipp  Diehl 
    • Hugstetterstr.55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • UHZ Freiburg - Bad KrozingenKardiologie & Angiologie I
    • Mr.  Prof. Dr. med.  Christoph  Bode 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.