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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Heidelberg University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01335815
First received: April 13, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 13, 2011
Last Updated: April 13, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 19, 2014