- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00416299
Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery
January 29, 2009 updated by: Klinikum Ludwigshafen
Observational Cohort Study on the Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery
To evaluate the use of new cardiac biomarker for the prediction of in-hospital cardiovascular complications in elderly patients undergoing elective cardiac surgery.
Study Overview
Status
Completed
Conditions
Detailed Description
Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP, cardiac troponin T (cTnT), pregnancy-associated plasma protein A (PAPP-A), ischemia-modified albumin (IMA), myeloperoxidase (MPO), metalloproteinase (MMP) soluble CD 40 ligand (sCD40L), and inflammatory cytokine levels will be measured in 100 elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass before induction of anesthesia and 12 h, 24 h, and 48 h after surgery.
Optimum discriminators for prediction of postoperative cardiovascular complications wil be determined by the use of receiver operating characteristics (ROC) curves analyses.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ludwigshafen, Germany, 67063
- Department of Anesthesiology and Intensive Care Medicine Klinikum Ludwigshafen
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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
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients aged 75 years or older undergoing elective cardiac surgery with CPB
Exclusion Criteria:
- positive cardiac troponin T test within the week before surgery
- patients undergoing emergent procedures
- patients with preoperative mechanical cardiac support
- patients undergoing hemodialysis
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stefan W. Suttner, MD, Klinikum Ludwigshafen
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
May 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
December 26, 2006
First Submitted That Met QC Criteria
December 26, 2006
First Posted (Estimate)
December 27, 2006
Study Record Updates
Last Update Posted (Estimate)
January 30, 2009
Last Update Submitted That Met QC Criteria
January 29, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KliLuNTproBNP
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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