Rate of Microbial Colonization Over Native Calcified Cardiac Valves

• Conditions: Degenerative Cardiac Valve Disease; Coronary Artery Bypass Surgery Patients

• Registration Number: NCT01409525
• Lead Sponsor: Rambam Health Care Campus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-28
• Status Verified: 2011-08
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-03
• Last Update Submitted: 2011-08-03
• Study First Posted: 2011-08-04
• Last Update Posted: 2011-08-04
• Primary Completion: 2012-07
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.	Patients will be followed for the duration of their hospitalization, average of 5 days.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Rambam health care campus; 🇮🇱 Haifa, Israel