- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388893
Endocarditis Registry of the University Hospital of Cologne (ER-UHC)
October 16, 2018 updated by: Guido Michels, University of Cologne
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guido Michels, Prof. Dr.
- Phone Number: ++49-221-478-32401
- Email: guido.michels@uk-koeln.de
Study Contact Backup
- Name: Norma Jung, Dr.
- Phone Number: ++49-221-478-0
- Email: norma.jung@uk-koeln.de
Study Locations
-
-
-
Cologne, Germany, 50937
- Recruiting
- Heart Center of the University of Cologne
-
Contact:
- Guido Michels, Prof. Dr.
- Phone Number: ++49-221-478-32401
- Email: guido.michels@uk-koeln.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients with definitive IE
Description
Inclusion Criteria:
- All patients with patients with definitive infective endocarditis
Exclusion Criteria:
- childs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 1 year
|
1-year all-cause mortality
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inhospital all-cause mortality
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guido Michels, Prof. Dr., Heart Center, University of Cologne, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 13, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
October 17, 2018
Last Update Submitted That Met QC Criteria
October 16, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-221 (Ethics committee of the University of Cologne)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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