Rate of Microbial Colonization Over Native Calcified Cardiac Valves

NCT01409525 | Unknown

• 1 other identifier: RMB-0233.CTIL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Cardiac Valve Disease; Coronary Artery Bypass Surgery Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

cardiac surgery patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cardiac valve tissue

Study Officials

• Liran Shani, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liran Shani, MD

CONTACT

972-8542631; l_shani@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 4, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

IL (1)