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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bacterial Infections
Cardiovascular Diseases
Cardiovascular Infections
Heart Diseases
Infection

ClinicalTrials.gov processed this record on October 23, 2014