Rate of Microbial Colonization Over Native Calcified Cardiac Valves

NCT ID: NCT01409525

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Cardiac Valve Disease Coronary Artery Bypass Surgery Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cardiac surgery patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Rambam Health Care Campus- cardiac surgery department

Principal Investigators

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Liran Shani, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Liran Shani, MD

Role: CONTACT

972-8542631

Facility Contacts

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Liran Shani, MD

Role: primary

972-4-8542631

Other Identifiers

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RMB-0233.CTIL

Identifier Type: -

Identifier Source: org_study_id

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