High-sensitivity Troponin in Cardiac Surgery

NCT01913873 | Completed Phase 4

• 1 other identifier: NATH201301
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

High-sensitivity Cardiac Troponin; Creatinin Kinase MB; Cardiac Surgery; Myocardial injury; Myocardial infarction; Concentration change

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Determination of threshold values for high-sensitivity troponin T and CK-MB cardiac biomarkers that strongly suggest substantial myocardial damage and necrosis.

  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 Outcomes (1)

• Twelve-lead Electrocardiographs (ECGs)

  the day prior to surgery, immediately upon arrival at the ICU, and then 24 and 48 hours post-surgery

Study Arms (1)

Cardiac biomarkers concentration changes

EXPERIMENTAL

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

Interventions

serum concentration changes cardiac biomarkers OTHER

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.

Cardiac biomarkers concentration changes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onze Lieve Vrouw Hospital: lead
• Roche Farma, S.A: collaborator

Study Sites (1)

Intensive Care Unit, OLV Hospital Aalst, Belgium

Aalst, East-Flanders, 9300, Belgium

Location

Related Publications (6)

• 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.

  PMID: 20685679 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.107.182882. Epub 2007 Mar 23. No abstract available.

  PMID: 17384331 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.107.182881. Epub 2007 Mar 23. No abstract available.

  PMID: 17384332 BACKGROUND

• 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. doi: 10.1016/s0003-4975(99)01294-1.

  PMID: 10735677 BACKGROUND

• 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, Menasche 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. No abstract available.

  PMID: 22922414 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000109489.71945.BD. Epub 2004 Jan 19.

  PMID: 14732755 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 1, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

BE (1)