Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery

This study has been completed.

Sponsor:

Information provided by:

Klinikum Ludwigshafen

ClinicalTrials.gov Identifier:

NCT00416299

First received: December 26, 2006

Last updated: January 29, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 26, 2006

Last Updated Date

January 29, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00416299 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery

Official Title ^ICMJE

Observational Cohort Study on the Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery

Brief Summary

To evaluate the use of new cardiac biomarker for the prediction of in-hospital cardiovascular complications in elderly patients undergoing elective cardiac surgery.

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 ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Cardiac Surgery

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

August 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

75 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00416299

Other Study ID Numbers ^ICMJE

KliLuNTproBNP

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Klinikum Ludwigshafen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stefan W. Suttner, MD

Klinikum Ludwigshafen

Information Provided By

Klinikum Ludwigshafen

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top