Rate of Microbial Colonization Over Native Calcified Cardiac Valves

Rambam Health Care Campus

Status: Unknown

Conditions: Coronary Artery Bypass Surgery Patients; Degenerative Cardiac Valve Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01409525

RMB-0233.CTIL

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

200 participants in 1 patient group

cardiac surgery patients