Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Machine Learning-Based Risk Profile Classification of Patients Undergoing Elective Heart Valve Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03724123
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
Institute of Bioinformatics, JKU Linz
Information provided by (Responsible Party):
Jens Meier, Kepler University Hospital

Brief Summary:
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.

Condition or disease
Heart Valve Diseases Surgery--Complications

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 2229 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Machine Learning-Based Risk Profile Classification of Patients Undergoing Elective Heart Valve Surgery
Actual Study Start Date : January 1, 2008
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jens Meier, Prof. Dr., Kepler University Hospital
ClinicalTrials.gov Identifier: NCT03724123    
Other Study ID Numbers: K-82-15
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jens Meier, Kepler University Hospital:
random forests
heart valve surgery
support vector machines
artificial neural networks
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases