- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724123
Machine Learning-Based Risk Profile Classification of Patients Undergoing Elective Heart Valve Surgery
October 26, 2018 updated by: Jens Meier, Kepler University Hospital
Machine learning methods potentially provide a highly accurate and detailed assessment of expected individual patient risk before elective cardiac surgery.
Correct anticipation of this risk allows for improved counseling of patients and avoidance of possible complications.
The investigators therefore investigate the benefit of modern machine learning methods in personalized risk prediction in patients undergoing elective heart valve surgery.
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators performe a monocentric retrospective study in patients who underwent elective heart valve surgery between January 1, 2008, and December 31, 2014 at our center.
The investigators use random forests, artificial neural networks, and support vector machines to predict the 30-days mortality from a subset of demographic and preoperative parameters.
Exclusion criteria were re-operation of the same patient, patients that needed anterograde cerebral perfusion due to aortic arch surgery, and patients with grown up congenital heart disease.
Study Type
Observational
Enrollment (Actual)
2229
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent heart valve surgery of any kind between 2008-01-01 and 2014-12-31 were included.
Description
Inclusion Criteria:
* Patients who underwent heart valve surgery of any kind between 2008-01-01 and 2014-12-31 were included.
Exclusion Criteria:
- re-operation of the same patient
- patients that needed anterograde cerebral perfusion due to aortic arch surgery
- patients with grown-up congenital heart disease
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve for different prediction models
Time Frame: Patients will included from 01.01.2008 - 31.12.2014
|
Three different predictions models will be used.
|
Patients will included from 01.01.2008 - 31.12.2014
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2008
Primary Completion (Actual)
December 31, 2014
Study Completion (Actual)
December 31, 2014
Study Registration Dates
First Submitted
October 25, 2018
First Submitted That Met QC Criteria
October 26, 2018
First Posted (Actual)
October 30, 2018
Study Record Updates
Last Update Posted (Actual)
October 30, 2018
Last Update Submitted That Met QC Criteria
October 26, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K-82-15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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