Rate of Microbial Colonization Over Native Calcified Cardiac Valves

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

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 Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 200 eligible adult subjects, scheduled to undergo elective cardiac surgery in RAMBAM medical center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
cardiac surgery patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease	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.	Patients will be followed for the duration of their hospitalization, average of 5 days.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ANTICIPATED): July 1, 2012
• Study Completion (ANTICIPATED): October 1, 2012

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (ESTIMATE): August 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 4, 2011
• Last Update Submitted That Met QC Criteria: August 3, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Infections; Communicable Diseases; Heart Valve Diseases
• Other Study ID Numbers: RMB-0233.CTIL