|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01409525 |
|
Date of registration:
|
28/07/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Rate of Microbial Colonization Over Native Calcified Cardiac Valves
|
|
Scientific title:
|
Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves |
|
Date of first enrolment:
|
August 2011 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01409525 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
Liran Shani, MD |
|
Address:
|
|
|
Telephone:
|
972-8542631 |
|
Email:
|
l_shani@rambam.health.gov.il |
|
Affiliation:
|
|
|
|
Name:
|
Liran Shani, MD |
|
Address:
|
|
|
Telephone:
|
972-4-8542631 |
|
Email:
|
l_shani@rambam.health.gov.il |
|
Affiliation:
|
|
|
|
Name:
|
Liran Shani, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rambam Health Care Campus |
|
|
Key inclusion & exclusion 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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Degenerative Cardiac Valve Disease
|
|
Coronary Artery Bypass Surgery Patients
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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.]
|
|
Secondary ID(s)
|
|
RMB-0233.CTIL
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|