Endocarditis Registry of the University Hospital of Cologne (ER-UHC)

NCT ID: NCT02388893

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2022-12-31

Brief Summary

As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry is a prospective, national registry of patients with IE. From January 2013 data from endocarditis board were prospectively recorded using standard definitions during the hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.

Detailed Description

The primary endpoint will be the 1 year all-cause mortality after treatment begins of IE. We will use 1 year all-cause mortality as the primary endpoint because it has been demonstrated that a period of at least 6 months is necessary to offset the early postoperative mortality related to valve surgery. We also looked at all-cause in-hospital mortality as a secondary endpoint.

Conditions

Infective Endocarditis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All patients with patients with definitive infective endocarditis

Exclusion Criteria

• childs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Guido Michels

Dr. Guido Michels

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guido Michels, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Heart Center, University of Cologne, Germany

Locations

Heart Center of the University of Cologne

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Guido Michels, Prof. Dr.

Role: CONTACT

guido.michels@uk-koeln.de

++49-221-478-32401

Norma Jung, Dr.

Role: CONTACT

norma.jung@uk-koeln.de

++49-221-478-0

Facility Contacts

Guido Michels, Prof. Dr.

Role: primary

guido.michels@uk-koeln.de

++49-221-478-32401

Other Identifiers

14-221

Identifier Type: OTHER

Identifier Source: secondary_id

14-221

Identifier Type: -

Identifier Source: org_study_id