How to Improve Diagnosis in Infective Endocarditis

This study is currently recruiting participants.

Verified by University of Aarhus, February 2009

First Received: August 31, 2007 Last Updated: February 4, 2009 History of Changes

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00524212

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:	Prospective

Resource links provided by NLM:

MedlinePlus related topics: Endocarditis

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Estimated Enrollment:	600
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2009

Groups/Cohorts
A Prospective, controlled, blinded study of clinical/TEE criteria of IE compare to clinical/blood test criteria of IE.

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

Contacts

Contact: Jane B Knudsen, Dr.

+4589496241

KnudsenJB@Gmail.com

Locations

Denmark
Department of Cardiology, Aarhus University Hospital	Recruiting
Aarhus, Denmark, 8200
Contact: Jane B Knudsen, Dr. 89496241 KnudsenJB@Gmail.com

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:	Dept. of Cardiology, Aarhus University Hospital, Skejby - Denmark ( Jane Byriel Knudsen )
Study ID Numbers:	06-10-B640-A1205-22345, 20060181, SUN-2007-653
Study First Received:	August 31, 2007
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00524212 History of Changes
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency

Study placed in the following topic categories:

Bacterial Infections
Bacterial Endocarditis
Heart Diseases
Endocarditis, Bacterial

Endocarditis, Infective
Cardiovascular Infections
Infective Endocarditis
Endocarditis

Additional relevant MeSH terms:

Bacterial Infections
Heart Diseases
Endocarditis, Bacterial
Cardiovascular Diseases

Cardiovascular Infections
Infection
Endocarditis

ClinicalTrials.gov processed this record on July 02, 2009