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Clinical Trials/NCT01409525
NCT01409525
Unknown
Not Applicable

Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Rambam Health Care Campus1 site in 1 country200 target enrollmentStarted: August 2011Last updated:
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ConditionsDegenerative Cardiac Valve DiseaseCoronary Artery Bypass Surgery Patients

Overview

Phase
Not Applicable
Enrollment
200
Locations
1
Primary Endpoint
To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed
  • •Male or Female subject, 50 years or older
  • •Subjects are scheduled to go through any cardiac valve replacement or repair due to degenerative calcified process. For control, subjects with no evidence of valve disease

Exclusion Criteria

  • •Subjects have an established or indicated history of IE.
  • •Subjects have complaint that might indicate IE- intermittent fever and physical finding according to IE diagnosis criteria (not including a heart murmur)
  • •Subjects are current users or have a close history of drug abuse

Outcomes

Primary Outcomes

To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.

Time Frame: Patients will be followed for the duration of their hospitalization, average of 5 days.

Secondary Outcomes

  • Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease(Patients will be followed for the duration of their hospitalization, average of 5 days.)

Investigators

Sponsor Class
Other

Study Sites (1)

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