Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Coronary Artery Bypass Surgery Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01409525
• Other study ID #: RMB-0233.CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 28, 2011
• Last updated: August 3, 2011
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: August 2011
• Source: Rambam Health Care Campus
• Contact: Liran Shani, MD
• Phone: 972-8542631
• Email: l_shani[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Coronary Artery Bypass Surgery Patients
• Degenerative Cardiac Valve Disease
• Heart Valve Diseases
• Infection

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No