High-sensitivity Troponin in Cardiac Surgery

March 17, 2015 updated by: Guy CAMMU, Onze Lieve Vrouw Hospital

High-sensitivity Cardiac Troponin and CK-MB Concentrations in Patients Undergoing Cardiac Surgery

Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is expected. The level of injury can be shown by measuring the blood levels of specific molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute cardiac care to diagnose a myocardial infarction.

Postoperative heart infarction remains a frequent and important complication after heart surgery.Therefore it is important to recognize any cardiac event in patients who underwent heart surgery. Although different diagnostic tools can be used to recognize these events, few is known about the value of those cardiac biomarkers to diagnose a myocardial infarction after heart surgery.

In this study the investigators will describe the concentration changes of those cardiac biomarkers over time in patients undergoing heart surgery, and the investigators will try to establish a upper level value who could indicate heart infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective interventional mono centre study. High-sensitivity troponin and CK-MB will be measured at different point of times in all adult patients undergoing cardiac surgery.

Experiments are conducted at the O.L.V. Hospital, Aalst, Belgium, in a fully equipped operating room and intensive care facility and in the presence of board-certified anesthesiologists for safety reasons. After approval by the institutional ethics committee and written informed consent, all adult patients scheduled for different types of cardiac surgery between June 2013 and June 2014 will be enrolled. Collected data include demographic information, presence of co-morbid conditions and basic preoperative laboratory testing (including Hs-cTn and CK-MB) (Table 1) as well as per- and postoperative factors (Table 2).

Four different surgeons will perform the surgeries. The revascularization strategy and work method are chosen according to each surgeon's preference and good clinical practice. Standard monitoring is used in all patients. Anaesthesia management is at the discretion of the attending anaesthesiologist and according to good clinical practice.

Serum levels of CK-MB and Hs-cTn will be measured at induction of anaesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery. Samples are analysed at the department of Clinical Biochemistry of our institution with the Elecsys Troponin T hs immuno-assay. Lower limit of quantification being 0,14 Nano gram/L (company data).

Twelve-lead ECGs obtained routinely the day prior to surgery, immediately upon arrival at the ICU, and then 24 and 48 hours post-surgery will be retrospectively reviewed by a cardiologist blinded to all other data for evidence of new postoperative MI.

All cardiac events, as described by the Third Global MI Task Force definition of MI, will be noted. Additional ECG or transesophageal echocardiography will be done at the discretion of the attending ICU physician, according to ICU protocols and good clinical practice.

Approved automated record keeping system (MetaVision Suite, iMDSoft, the Netherlands) will be used in the ICU. The principal investigator and/or co-investigators will supervise data handling.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

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
    • East-Flanders
      • Aalst, East-Flanders, Belgium, 9300
        • Intensive Care Unit, OLV Hospital Aalst, Belgium

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Each participant must be older than 18 years
  • Undergoing cardiac surgery
  • Each participant must have the mental capacity to decide whether he takes part in the trial or not.
  • Each participant must voluntarily give his written informed consent.

Exclusion Criteria:

  • Patients with severe or end-stage renal insufficiency.
  • Insertion of assist devices.
  • Surgery on urgent basis, that is, the same day after their coronary angiogram.

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

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cardiac biomarkers concentration changes

In 2012 the Third Global MI Task Force has presented a third universal definition of MI implying that MI associated with CABG is arbitrarily defined by elevation of cardiac biomarkers values > 10x99th percentile URL in patients with normal baseline cTn values (≤ 99th percentile URL), in addition with either (i) new pathological Q waves or new LBBB (left bundle branch block), or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

In this study we will measure the concentration changes over time of cardiac biomarkers (hs-cTN and CK-MB) and establish a threshold value for myocardial injury, diagnosed by ECG and approved -if necessary- by echocardiography.
Other: serum concentration changes cardiac biomarkers
Serum concentration determination for cardiac biomarkers (CK-MB and Hs-cTn) preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
high-sensitivity troponin T concentration changes over time in patients undergoing cardiac surgery
Time Frame: from 12 hours preoperatively to 48 hours postoperatively
Serum levels of Hs-cTn (high-sensitivity cardiac troponin assays) will be measured from 12 hours preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
from 12 hours preoperatively to 48 hours postoperatively
CK-MB concentration changes over time in patients undergoing cardiac surgery
Time Frame: From 12 hours preoperatively to 48 hours postoperatively
Serum levels of CK-MB will be measured 12 hours preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
From 12 hours preoperatively to 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of threshold values for high-sensitivity troponin T and CK-MB cardiac biomarkers that strongly suggest substantial myocardial damage and necrosis.
Time Frame: every 3 postoperative hours for the first 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery
Postoperative myocardial infarction remains a frequent and important complication after cardiac surgery. In 2012 the Third Global MI Task Force has presented a third universal definition of myocardial infarction (MI) implying that MI associated with coronary artery bypass grafting (CABG) is arbitrarily defined by elevation of cardiac biomarkers values > 10x99th percentile URL in patients with normal baseline cTn values (≤ 99th percentile URL), in addition with either (i) new pathological Q waves or new LBBB (left bundle branch block), or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Although some suggest that ECG, myocardial scan, and CK-MB criteria underestimate the prevalence of MI after CABG, few is known about the established threshold values for hs-cTn after valve surgery or combined surgery.
every 3 postoperative hours for the first 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twelve-lead Electrocardiographs (ECGs)
Time Frame: the day prior to surgery, immediately upon arrival at the ICU, and then 24 and 48 hours post-surgery
Twelve-lead ECGs obtained routinely will be retrospectively reviewed by a cardiologist blinded to all other data for evidence of new postoperative MI.
the day prior to surgery, immediately upon arrival at the ICU, and then 24 and 48 hours post-surgery

Collaborators and Investigators

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

Sponsor

Onze Lieve Vrouw Hospital

Collaborators

Roche Farma, S.A

Investigators

  • Principal Investigator: Nathalie De Mey, MD, OLV Hospital Aalst, Belgium
  • Principal Investigator: Koen De Decker, MD, OLV Hospital Aalst, Belgium
  • Principal Investigator: Guy Cammu, MD,PhD, OLV Hospital Aalst, Belgium
  • Study Chair: Inger Brandt, MD, OLV Hospital Aalst, Belgium
  • Study Chair: Pierre Couture, MD, Montreal Heart Institute, Quebec, Canada
  • Study Chair: William Wijns, MD, OLV Hospital Aalst, Belgium
  • Study Chair: Jan Verbeke, MD, OLV Hospital Aalst, Belgium
  • Study Chair: Ivan Degrieck, MD, OLV Hospital Aalst, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (ESTIMATE)

August 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NATH201301

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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