Rate of Microbial Colonization Over Native Calcified Cardiac Valves

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01409525
First received: July 28, 2011
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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
Degenerative Cardiac Valve Disease
Coronary Artery Bypass Surgery Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

cardiac valve tissue


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiac surgery patients

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409525

Contacts
Contact: Liran Shani, MD 972-8542631 l_shani@rambam.health.gov.il

Locations
Israel
Rambam health care campus Not yet recruiting
Haifa, Israel
Contact: Liran Shani, MD    972-4-8542631    l_shani@rambam.health.gov.il   
Principal Investigator: Liran Shani, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Liran Shani, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Liran Shani, Rambam Health Care Campus- cardiac surgery department
ClinicalTrials.gov Identifier: NCT01409525     History of Changes
Other Study ID Numbers: RMB-0233.CTIL
Study First Received: July 28, 2011
Last Updated: August 3, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014