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Rate of Microbial Colonization Over Native Calcified Cardiac Valves

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409525
First Posted: August 4, 2011
Last Update Posted: August 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  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

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. ]

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. ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 28, 2011
First Posted: August 4, 2011
Last Update Posted: August 4, 2011
Last Verified: August 2011

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