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How to Improve Diagnosis in Infective Endocarditis

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT00524212
Collaborator
(none)
761
Enrollment
1
Location
26
Duration (Months)
29.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose is to exam prospective if simple clinical information in combination with a normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Despite progress in surgical and medical treatment, infective endocarditis is still associated with high morbidity and mortality.

    The variable clinical presentation of IE makes the diagnosis a clinical challenge.

    Procalcitonin is a precursor from the hormone calcitonin and also a marker of systemic bacterial infections.

    The purpose of this study is:

    • to investigate the diagnostic value of serum procalcitonin (PCT), C-reactive protein (CRP) and sedimentation rate (SR) when IE is suspected.

    • to investigate if a retrospectively generated clinical model suitable for exclusion of IE can be confirmed prospectively.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    761 participants
    Time Perspective:
    Prospective
    Official Title:
    Ph. D Student, Jane Byriel Knudsen, Aarhus University
    Study Start Date :
    Mar 1, 2007
    Actual Study Completion Date :
    May 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    IE confirmed IE rejected

    Prospective, controlled, blinded study of clinical/TEE criteria of IE compare to clinical/blood test criteria of IE.
    IE confirmed IE rejected

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Patients > or = 18 year with suspected or verified Infective Endocarditis

      • By word of mouth or in writing consent

      Exclusion Criteria:
      • Incapacity

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Cardiology, Aarhus University Hospital Aarhus Denmark 8200

      Sponsors and Collaborators

      • University of Aarhus

      Investigators

      • Principal Investigator: Jane B Knudsen, Dr., Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00524212
      Other Study ID Numbers:
      • 06-10-B640-A1205-22345
      • 20060181
      • SUN-2007-653
      First Posted:
      Sep 3, 2007
      Last Update Posted:
      Jan 20, 2010
      Last Verified:
      Jan 1, 2010
      Additional relevant MeSH terms:
      Endocarditis, Bacterial
      Endocarditis

      Study Results

      No Results Posted as of Jan 20, 2010