The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery

April 16, 2019 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Elevated troponin (Tn) hsTnT levels occur as a result of myocardial damage and are used in the diagnosis of myocardial infarction (MI). However, there are multiple different causes that also result in abnormal Tn levels, such as direct myocardial-cell injury, impaired renal excretion and sepsis. Because of this, elevated Tn level is a common finding in hospitalized patients.

Several studies on patients admitted to the intensive care unit (ICU) without MI show that Tn elevation is a mortality risk factor and an independent predictor of hospital mortality.

Up till now it is not yet known if the routine measurement of Tn in elderly patients undergoing surgery can significantly improve their outcome and that is the primary aim of this study. In addition, it is not known what the impact could be if a diastolic function assessment could be performed peri-operatively.

This study will examine the correlation between elevated Tn levels in elderly patients undergoing major surgery and their short-term outcome (in-hospital). Before and immediately after surgery, diastolic function will be assessed by means of transthoracic echocardiography (TTE).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Jette, Vlaams Brabant, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All surgical patients above 75 years old

Description

Inclusion Criteria:

  • All patients ≥75 y undergoing elective and major surgery till we have collected an entire dataset of 100 patients.
  • Only those patients will be included who are planned for elective and major surgery.

Exclusion Criteria:

  • Patients under the age of 75
  • Intraoperative mortality
  • Eye surgery
  • Cardiac or thoracic surgery
  • Patients undergoing surgery which is not withheld as major surgery
  • For patients undergoing multiple surgeries for the same indication and during the same hospitalization, only the first surgery will be included

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
level of cardiac troponin and diastolic function assessment by means of transthoracic echocardiography
Diagnostic test: level of cardiac troponin
blood test
Diagnostic test: diastolic function assessment
transthoracic echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical mortality
Time Frame: 30 days
30 days mortality
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diastolic function
Time Frame: 3 days
transthoracic echocardiography
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: jan Poelaert, PhD, MD, Universitair Ziekenhuis Brussel
  • Study Chair: Patrice Forget, PhD, MD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

May 28, 2020

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Troponin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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