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CompletedNCT02394288Updated Mar 21, 2016

Perioperative Cardiac Troponin Levels in Healthy Adults

An observational study in Extremity Orthopedic Surgery, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-03-21.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 35 Years
Sex
All
01

Study summary

This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations.

02

Conditions studied

  • Extremity Orthopedic Surgery

Keywords

  • Cardiac Troponin
  • Perioperative Period
  • surgery
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing extremity surgery without history of cardiovascular disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-35 years
  • Extremity orthopedic or trauma surgery: leg, hip, arm, shoulder.
  • Planned overnight hospital admission
  • No cardiac risk factors (Lee's Revised Cardiac Risk Index Class 1)
  • American Society of Anesthesiologists (ASA) physical status I-II

Exclusion criteria

Exclusion Criteria:

  • Any history or symptoms of cardiac disease
  • Kidney or liver disease
  • Recent or current trauma to the trunk or head
  • Persons with increased vulnerability (e.g. cognitive limitations, prisoners,…)
  • Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Adults without cardiac disease

    Extremity orthopedic or trauma surgery

    Procedure: Extremity orthopedic or trauma surgery

Interventions

  • ProcedureExtremity orthopedic or trauma surgery

    hip, leg, shoulder, arm

06

What researchers measure

Primary outcomes

  1. Perioperative change of high-sensitivity cardiac troponin plasma level

    3 samples: 1. Preoperative, 2. POD 0, and 3. POD 1

    Time frame: 24 hours preoperatively to postoperative day (POD) 1

Secondary outcomes

  1. Peak high-sensitivity cardiac troponin plasma level

    3 samples: 1. Preoperative, 2. POD 0, and 3. POD 1

    Time frame: 24 hours preoperatively to POD 1

  2. Incidence rate of high-sensitivity cardiac troponin plasma level elevation

    3 samples: 1. Preoperative, 2. POD 0, and 3. POD 1

    Time frame: 24 hours preoperatively to POD 1

07

Study locations

1 site
  • Division of General Anaesthesia and Intensive Care Medicine, Medical University of Vienna
    Vienna, 1090, Austria
08

References and documents

Publications

  • Duma A, Wagner C, Titz M, Maleczek M, Hupfl M, Weihs VB, Samaha E, Herkner H, Szekeres T, Mittlboeck M, Scott MG, Jaffe AS, Nagele P. High-sensitivity cardiac troponin T in young, healthy adults undergoing non-cardiac surgery. Br J Anaesth. 2018 Feb;120(2):291-298. doi: 10.1016/j.bja.2017.09.001. Epub 2017 Dec 5. PubMed 29406178 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2015, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2015
First posted
Mar 20, 2015
Start
Mar 2015
Primary completionActual
Mar 2016
CompletionActual
Mar 2016
Last update
Mar 21, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02394288
Lead sponsor
Medical University of Vienna
Collaborators
Washington University School of Medicine
Responsible party
Andreas Duma (MD, MSc, Medical University of Vienna) — Principal investigator
First posted
Mar 20, 2015
Start date
Mar 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Mar 21, 2016

Study contacts

Andreas Duma, MD, MSc
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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