How to Improve Diagnosis in Infective Endocarditis

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00524212
First received: August 31, 2007
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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
Endocarditis, Bacterial

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ph. D Student, Jane Byriel Knudsen, Aarhus University

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Biospecimen Retention:   Samples Without DNA

A venous blood sample was obtained from each patients and all samples were centrifuged and immediately frozen.


Enrollment: 761
Study Start Date: March 2007
Study Completion Date: May 2009
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 31, 2007
Last Updated: January 19, 2010
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on April 14, 2014