NCT02388893

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

9.9 years

First QC Date

March 9, 2015

Last Update Submit

October 16, 2018

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    1-year all-cause mortality

    1 year

Secondary Outcomes (1)

  • Inhospital all-cause mortality

    1 month

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with definitive IE

You may qualify if:

  • All patients with patients with definitive infective endocarditis

You may not qualify if:

  • childs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center of the University of Cologne

Cologne, 50937, Germany

RECRUITING

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Guido Michels, Prof. Dr.

    Heart Center, University of Cologne, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guido Michels, Prof. Dr.

CONTACT

++49-221-478-32401guido.michels@uk-koeln.de

Norma Jung, Dr.

CONTACT

++49-221-478-0norma.jung@uk-koeln.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Guido Michels

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 17, 2015

Study Start

January 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

DE(1)