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How to Improve Diagnosis in Infective Endocarditis

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ClinicalTrials.gov Identifier: NCT00524212
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
University of Aarhus

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
Endocarditis, Bacterial

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis
U.S. FDA Resources

Group/Cohort
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



Biospecimen Retention:   Samples Without DNA
A venous blood sample was obtained from each patients and all samples were centrifuged and immediately frozen.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The cohort was selected from all the patients admitted to the tertiary hospital (the initial diagnosis was infective endocarditis)
Criteria

Inclusion Criteria:

  • Patients > or = 18 year with suspected or verified Infective Endocarditis
  • By word of mouth or in writing consent

Exclusion Criteria:

  • Incapacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524212


Locations
Denmark
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

Responsible Party: Jane Byriel Knudsen, Dept. of Cardiology, Aarhus University Hospital, Skejby - Denmark
ClinicalTrials.gov Identifier: NCT00524212     History of Changes
Other Study ID Numbers: 06-10-B640-A1205-22345
20060181
SUN-2007-653
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection