Perioperative Myocardial InfarctionsNCT01335815
High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Total Endoprosthesis
An observational study of Perioperative Myocardial Infarctions and Pulmonary Embolism, run by Heidelberg University at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioperative Myocardial Infarctions, Pulmonary Embolism
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients with elective knee and hip endoprothesis
Who may be able to join
- Consecutive patients with elective knee and hip endoprosthesis
Who cannot join
- Not willing or not able to take part in the observational trial
- No written inform consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Evangelos Giannitsis, Prof. Dr., 004962215638686, Evangelos_Giannitsis@med.uni-heidelberg.de
About this study
Official title: High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Knee and Hip Endoprosthesis
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.
Read the 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.
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| elective knee and limb endoprothesis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of perioperative myocardial infarction and pulmonary embolism
Measured: Until 96h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Myocardial InfarctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Evangelos Giannitsis, Prof. Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335815
- Sponsor's protocol ID
- TnT hs 3
- Status last verified
- Apr 2011
- First submitted
- 13 Apr 2011
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Knee and Hip Endoprosthesis
- ClinicalTrials.gov ID
- NCT01335815
- Acronym / sponsor ID
- TnT hs 3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elective knee and limb endoprothesis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with elective knee and hip endoprothesis
Key inclusion criteria (1 listed)
- Consecutive patients with elective knee and hip endoprosthesis
Key exclusion criteria (2 listed)
- Not willing or not able to take part in the observational trial
- No written inform consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of perioperative myocardial infarction and pulmonary embolism
Time frame: Until 96h after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelos Giannitsis, Prof. Dr. principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Myocardial Infarctions and Pulmonary Embolism, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact evangelos Giannitsis, Prof. Dr. (0049-6221-56-38686, Evangelos_Giannitsis@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of perioperative myocardial infarction and pulmonary embolism (time frame: Until 96h after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.