Rate of Microbial Colonization Over Native Calcified Cardiac Valves
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ClinicalTrials.gov Identifier: NCT01409525
Verified August 2011 by Rambam Health Care Campus. Recruitment status was: Not yet recruiting
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.
Condition or disease
Degenerative Cardiac Valve DiseaseCoronary Artery Bypass Surgery Patients
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 Outcome Measures
Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease [ Time Frame: Patients will be followed for the duration of their hospitalization, average of 5 days. ]
Baseline demographic, clinical and laboratory parameters such as age, gender, medical history, complete blood count and biochemistry profile will be compared between research group (degenerative cardiac valve disease) and control group (Isolated coronary artery bypass graft surgery patients) by means of multivariate analysis and pattern recognition techniques.
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Ages Eligible for Study:
50 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Up to 200 eligible adult subjects, scheduled to undergo elective cardiac surgery in RAMBAM medical center.
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
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