High-sensitivity Troponin in Cardiac Surgery

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913873
• Other study ID #: NATH201301
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2013
• Last updated: March 17, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Heart; Dysfunction Postoperative, Cardiac Surgery
• Infarction
• Myocardial Infarction
• Myocardial Injury

Intervention

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.

Locations

Country	Name	City	State
Belgium	Intensive Care Unit, OLV Hospital Aalst, Belgium	Aalst	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
Onze Lieve Vrouw Hospital	Roche Farma, S.A

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

Apple FS, Jesse RL, Newby LK, Wu AH, Christenson RH; National Academy of Clinical Biochemistry; IFCC Committee for Standardization of Markers of Cardiac Damage. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical issues for biochemical markers of acute coronary syndromes. Circulation. 2007 Apr 3;115(13):e352-5. Epub 2007 Mar 23. — View Citation

Carrier M, Pellerin M, Perrault LP, Solymoss BC, Pelletier LC. Troponin levels in patients with myocardial infarction after coronary artery bypass grafting. Ann Thorac Surg. 2000 Feb;69(2):435-40. — View Citation

Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, Wu AH, Christenson RH; National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Circulation. 2007 Apr 3;115(13):e356-75. Epub 2007 Mar 23. — View Citation

Selvanayagam JB, Petersen SE, Francis JM, Robson MD, Kardos A, Neubauer S, Taggart DP. Effects of off-pump versus on-pump coronary surgery on reversible and irreversible myocardial injury: a randomized trial using cardiovascular magnetic resonance imaging and biochemical markers. Circulation. 2004 Jan 27;109(3):345-50. Epub 2004 Jan 19. — View Citation

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. — View Citation

Thygesen K, Mair J, Katus H, Plebani M, Venge P, Collinson P, Lindahl B, Giannitsis E, Hasin Y, Galvani M, Tubaro M, Alpert JS, Biasucci LM, Koenig W, Mueller C, Huber K, Hamm C, Jaffe AS; Study Group on Biomarkers in Cardiology of the ESC Working Group on Acute Cardiac Care. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J. 2010 Sep;31(18):2197-204. doi: 10.1093/eurheartj/ehq251. Epub 2010 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Twelve-lead Electrocardiographs (ECGs)	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	Yes
Primary	high-sensitivity troponin T concentration changes over time in patients undergoing cardiac surgery	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	Yes
Primary	CK-MB concentration changes over time in patients undergoing cardiac surgery	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	Yes
Secondary	Determination of threshold values for high-sensitivity troponin T and CK-MB cardiac biomarkers that strongly suggest substantial myocardial damage and necrosis.	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	Yes