American Journal of Cardiology
Volume 104, Issue 10 , Pages 1330-1335 , 15 November 2009

Comparison of Site-Reported and Core Laboratory-Reported Creatine Kinase-MB Values in Non–ST-Segment Elevation Acute Coronary Syndrome (from the International Trial SYNERGY)

  • Jason P. Linefsky, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • Min Lin, PhD

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • Karen S. Pieper, MS

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • Craig J. Reist, PhD

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • Lisa G. Berdan, PA-C

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • Elliott M. Antman, MD

      Affiliations

    • Brigham and Women's Hospital, Boston, Massachusetts
    • ,
  • Shaun G. Goodman, MD

      Affiliations

    • St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada
    • ,
  • John K. French, MB, ChB, PhD

      Affiliations

    • University of New South Wales, Sydney, New South Wales, Australia
    • ,
  • Sema Guneri, MD

      Affiliations

    • Dokuz Eylul Universitesi, Smyrna, Turkey
    • ,
  • Matthew T. Roe, MD, MHS

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • L. Kristin Newby, MD, MHS

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • Robert A. Harrington, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • James J. Ferguson, MD

      Affiliations

    • The Medicines Company, Parsippany, New Jersey
    • ,
  • Robert M. Califf, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • ,
  • Kenneth W. Mahaffey, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, North Carolina
    • Corresponding Author InformationCorresponding author: Tel: (919) 668-8845; fax: (919) 688-7059

Received 12 March 2009 ,Revised 19 June 2009 ,Accepted 19 June 2009.

References 

  1. Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined—a consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infraction. J Am Coll Cardiol. 2000;36:959–969
  2. SYNERGY Executive Committee. The SYNERGY trial: study design and rationale. Am Heart J. 2002;143:952–960
  3. The SYNERGY Trial Investigators. Enoxaparin vs unfractionated heparin in high-risk patients with non–ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA. 2004;292:45–54
  4. Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255–268
  5. Lin LI. A note on the concordance correlation coefficient. Biometrics. 2000;56:324–325
  6. Wu AHB, Apple FS, Gibler WB, Jesse RL, Warshaw MM, Valdes R. National Academy of Clinical Biochemistry Standards of Laboratory Practice: recommendation for the use of cardiac marker in coronary artery diseases. Clin Chem. 1999;45:1104–1121
  7. The Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy (PURSUIT) Trial Investigators (Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes). N Engl J Med. 1999;339:436–443
  8. Christenson RH, Vaidya H, Landt Y, Bauer RS, Green SF, Apple FA, et al. Standardization of creatine kinase-MB (CK-MB) mass assays: the use of recombinant CK-MB as a reference material. Clin Chem. 1999;45:1414–1423
  9. Panteghini M, Pagani F. AACC creatine kinase MB (CK-MB) standardization material used as manufacturer's working calibrator is unable to harmonize CK-MB results between 2 commercial immunoassays. Clin Chem. 2004;50:1711–1712
  10. Apple FS. Clinical and analytical issues confronting cardiac troponin I. Clin Chem. 1999;45:18–20
  11. Panteghini M, Bunk DM, Christenson RH, Katrukha A, Porter RA, Schimmel H, et al. I. Standardization of troponin I measurements: an update. Clin Chem Lab Med. 2008;46:1501–1506
  12. Akkerhuis KM, Deckers JW, Boersma E, Harrington RA, Stepinska J, Mahaffey KW, et al. Geographic variability in outcomes within an international trial of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes. Eur Heart J. 2000;21:371–381
  13. Apple FS, Murakami M, Panteghini M, Christenson RH, Dati F, Mair J, et al. International survey on the use of cardiac markers. Clin Chem. 2001;47:587–588
  14. Lagakos SW. The challenge of subgroup analyses: reporting without distorting. N Engl J Med. 2006;354:1667–1669
  15. Apple FS, Jesse RL, Newby K, Wu AHB, Christenson RH. 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;115:e342–e355
  16. Apple FS, Quist HE, Doyle PJ, Otto AP, Murakami MM. Plasma 99th percentile reference limits for cardiac troponin and creatine kinase MB mass for use with European Society of Cardiology/American College of Cardiology consensus recommendations. Clin Chem. 2003;49:1331–1336
  17. Guo Z, Wang Z, Wang X. Studies on the stability of creatine kinase isozymes. Biochem Cell Biol. 2003;81:9–16
  18. Buttery JE, Stuart S, Pannall PR. Stability of the CK-MB isoenzyme on routine storage. Clin Biochem. 1992;25:11–13

 The SYNERGY trial was funded by Sanofi-Aventis, Bridgewater, New Jersey.

PII: S0002-9149(09)01318-6

doi: 10.1016/j.amjcard.2009.06.056

American Journal of Cardiology
Volume 104, Issue 10 , Pages 1330-1335 , 15 November 2009

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