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Author Notes:

Address of correspondence: Akshay Bagai, MD, MHS; Terrence Donnelly Heart Center, St. Michael’s Hospital, University of Toronto, Ontario, Canada; Phone: (416) 864-6060, ext. 5783; Fax: (416) 864-5989; bagaia@smh.ca

See publication for full list of disclosures.

The content of this manuscript is solely the responsibility of the authors and does not necessarily reflect the views of the National Institutes of Health or the Department of Health and Human Services

Subject:

Research Funding:

The ISCHEMIA trial, which is discussed in this article, is supported by National Heart, Lung, and Blood Institute grant U01HL105907, in-kind donations from Abbott Vascular; Medtronic, Inc., St. Jude Medical, Inc., Volcano Corporation, Arbor Pharmaceuticals, LLC, AstraZeneca Pharmaceuticals, LP, Merck Sharp & Dohme Corp., and Omron Healthcare, Inc.; and by financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP.

Drs. Hochman and Maron have received NIH grant support for the ISCHEMIA trial.

Dr. Bangalore reports grant support from the NHLBI for the ISCHEMIA (U01HL105907) and ISCHEMIA-CKD trials (U01HL117905).

Dr. Maron reports receiving NIH grant support for the ISCHEMIA trial (U01HL105907).

Dr. Banerjee reports honoraria received from Medtronic, CSI, Gore and grants received from Boston Scientific Corporation, Merck, Astra Zeneca.

Dr. Goodman has received research grant support and speaker/consulting honoraria from Bayer and Roche.

Dr. Hochman reports being the PI for the ISCHEMIA trial for which, in addition to support by National Heart, Lung, and Blood Institute grant, there are in-kind donations from Abbott Vascular; Medtronic, Inc.; St. Jude Medical, Inc.; Volcano Corporation; Arbor Pharmaceuticals, LLC; AstraZeneca Pharmaceuticals, LP; Merck Sharp & Dohme Corp.; Omron Healthcare, Inc.; and financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • ACUTE CORONARY SYNDROME
  • JOINT EUROPEAN-SOCIETY
  • CARDIAC TROPONIN
  • CARDIOLOGY/AMERICAN COLLEGE
  • TASK-FORCE
  • POPULATION
  • COMMITTEE
  • OUTCOMES
  • TRIALS
  • VALUES

Use of troponin assay 99th percentile as the decision level for myocardial infarction diagnosis

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Journal Title:

American Heart Journal

Volume:

Volume 190

Publisher:

, Pages 135-139

Type of Work:

Article | Post-print: After Peer Review

Abstract:

Background The Universal Definition of Myocardial Infarction recommends the 99th percentile concentration of cardiac troponin in a normal reference population as part of the decision threshold to diagnose type 1 spontaneous myocardial infarction. Adoption of this recommendation in contemporary worldwide practice is not well known. Methods We performed a cohort study of 276 hospital laboratories in 31 countries participating in the National Heart, Lung, and Blood Institute–sponsored International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial. Each hospital laboratory's troponin assay manufacturer and model, the recommended assay's 99th percentile upper reference limit (URL) from the manufacturer's package insert, and the troponin concentration used locally as the decision level to diagnose myocardial infarction were ascertained. Results Twenty-one unique troponin assays from 9 manufacturers were used by the surveyed hospital laboratories. The ratio of the troponin concentration used locally to diagnose myocardial infarction to the assay manufacturer–determined 99th percentile URL was <1 at 19 (6.6%) laboratories, equal to 1 at 91 (31.6%) laboratories, >1 to ≤5 at 101 (35.1%) laboratories, >5 to ≤10 at 34 (11.8%) laboratories, and >10 at 43 (14.9%) laboratories. The variability in troponin decision level for myocardial infarction relative to the assay 99th percentile URL was present for laboratories in and outside of the United States, as well as for high- and standard-sensitivity assays. Conclusions There is substantial hospital-level variation in the troponin threshold used to diagnose myocardial infarction; only one-third of hospital laboratories currently follow the Universal Definition of Myocardial Infarction consensus recommendation for use of troponin concentration at the 99th percentile of a normal reference population as the decision level to diagnose myocardial infarction. This variability across laboratories has important implications for both the diagnosis of myocardial infarction in clinical practice as well as adjudication of myocardial infarction in clinical trials.

Copyright information:

© 2017 Elsevier Inc.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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