Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01409525

Enrollment

200

Registered

2011-08-04

Start date

2011-08-31

Completion date

2012-10-31

Last updated

2011-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Surgery Patients, Degenerative Cardiac Valve Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.	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.

Countries

Israel

Contacts

Primary ContactLiran Shani, MD

l_shani@rambam.health.gov.il972-8542631

Outcome results