High-sensitivity Troponin in Cardiac Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by Onze Lieve Vrouw Hospital
Sponsor:
Collaborator:
Roche Farma, S.A
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier:
NCT01913873
First received: July 29, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Heart; Dysfunction Postoperative, Cardiac Surgery
Myocardial Infarction
Myocardial Injury
Other: serum concentration changes cardiac biomarkers
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: High-sensitivity Cardiac Troponin and CK-MB Concentrations in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouw Hospital:

Primary Outcome Measures:
  • high-sensitivity troponin T concentration changes over time in patients undergoing cardiac surgery [ Time Frame: from 12 hours preoperatively to 48 hours postoperatively ] [ Designated as safety issue: Yes ]
    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.

  • CK-MB concentration changes over time in patients undergoing cardiac surgery [ Time Frame: From 12 hours preoperatively to 48 hours postoperatively ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Twelve-lead ECGs obtained routinely will be retrospectively reviewed by a cardiologist blinded to all other data for evidence of new postoperative MI.


Estimated Enrollment: 600
Study Start Date: August 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01913873

Contacts
Contact: Guy Cammu, MD, PhD +3253724111 guy.cammu@olvz-aalst.be
Contact: Nathalie De Mey, MD +3253724111 ext 1673 nathalie.de.mey@gmail.com

Locations
Belgium
Intensive Care Unit, OLV Hospital Aalst, Belgium Not yet recruiting
Aalst, East-Flanders, Belgium, 9300
Contact: Guy Cammu, MD, PhD    +3253724111    guy.cammu@olvz-aalst.be   
Contact: Nathalie De Mey, MD    +3253724111 ext 1673    natdemey@gmail.com   
Principal Investigator: Nathalie De Mey, MD         
Principal Investigator: Koen De Decker, MD         
Principal Investigator: Guy Cammu, MD         
Principal Investigator: Inger Brandt, MD         
Sub-Investigator: Pierre Couture, MD         
Sub-Investigator: William Wijns, MD         
Sub-Investigator: Jan Verbeke, MD         
Sub-Investigator: Ivan Degrieck, MD         
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
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
  More Information

Publications:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.

Responsible Party: Guy CAMMU, MD, PhD, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT01913873     History of Changes
Other Study ID Numbers: NATH201301
Study First Received: July 29, 2013
Last Updated: July 30, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Onze Lieve Vrouw Hospital:
High-sensitivity Cardiac Troponin
Creatinin Kinase MB
Cardiac Surgery
Myocardial injury
Myocardial infarction
Concentration change

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Wounds and Injuries
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014