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High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Total Endoprosthesis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01335815
First Posted: April 14, 2011
Last Update Posted: April 14, 2011
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.
Information provided by:
Heidelberg University
  Purpose
Summary: The purpose of the study is to prove if the biomarker high sensitive troponin T (hsTnT) and the biomarker of endogenous stress copeptin can serve as surrogate parameter of prognosis in patients with elective knee and hip total endoprosthesis.

Condition
Perioperative Myocardial Infarctions Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Knee and Hip Endoprosthesis

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Prevalence of perioperative myocardial infarction and pulmonary embolism [ Time Frame: Until 96h after operation ]

Biospecimen Retention:   Samples Without DNA
normal lab parameters

Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
elective knee and limb endoprothesis

Detailed Description:
Consecutively, high sensitive troponin T and copeptin will be measured in all patients with elective knee and hip endoprosthesis in the orthopedic department of the University of Heidelberg. The blood is taken during the routine blood testes if possible, on admission and the days 1-4 following the operation. Usual baseline characteristics are taken as well as usual blood results (hb, cholesterol and so on). Primary endpoint is the detection of perioperative myocardial infarction and pulmonary embolism.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
all patients with elective knee and hip endoprothesis
Criteria

Inclusion Criteria:

  • Consecutive patients with elective knee and hip endoprosthesis

Exclusion Criteria:

  • Not willing or not able to take part in the observational trial
  • No written inform consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335815


Contacts
Contact: evangelos Giannitsis, Prof. Dr. 0049-6221-56-38686 Evangelos_Giannitsis@med.uni-heidelberg.de

Locations
Germany
University of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Evangelos Giannitsis, Prof. Dr.    004962215638686    Evangelos_Giannitsis@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Evangelos Giannitsis, Prof. Dr. Heidelberg University
  More Information

Responsible Party: Prof. Dr. Evangelos Giannitsis, Department of Cardiology, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01335815     History of Changes
Other Study ID Numbers: TnT hs 3
First Submitted: April 13, 2011
First Posted: April 14, 2011
Last Update Posted: April 14, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Embolism
Pulmonary Embolism
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases