High-Sensitivity Cardiac Troponin-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI): Rationale and design for a multicenter, stepped-wedge, cluster-randomized trial.

Autor: Zhao Y; BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada., Izadnegahdar M; Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada., Lee MK; BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada., Kavsak PA; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada., Singer J; School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada., Scheuermeyer F; Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada., Udell JA; Division of Cardiovascular, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Women's College Hospital, Toronto, Ontario, Canada., Robinson S; Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada; Royal Jubilee Hospital, Victoria, British Columbia, Canada., Norris CM; Faculty of Nursing and Division of Cardiovascular Surgery, University of Alberta, Edmonton, Alberta, Canada; Cardiovascular Health and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, Alberta, Canada., Lyon AW; Department of Pathology and Laboratory Medicine, Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada., Pilote L; Divisions of General Internal Medicine and Clinical Epidemiology, Department of Medicine, Research Institute of the McGill University Health Centre and McGill University, Montréal, Québec, Canada., Cox J; Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada., Hassan A; Division of Cardiovascular Surgery, New Brunswick Heart Centre, Dalhousie University, Saint John, New Brunswick, Canada., Rychtera A; Patient Partners, Vancouver, British Columbia, Canada., Johnson D; Patient Partners, Vernon, British Columbia, Canada., Mills NL; British Heart Foundation Centre for Cardiovascular Science and Usher Institute, University of Edinburgh, Edinburgh, United Kingdom., Christenson J; Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada., Humphries KH; BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: karin.humphries@ubc.ca.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2020 Nov; Vol. 229, pp. 18-28. Date of Electronic Publication: 2020 Jun 25.
DOI: 10.1016/j.ahj.2020.06.013
Abstrakt: Despite evidence that high-sensitivity cardiac troponin (hs-cTn) levels in women are lower than in men, a single threshold based on the 99th percentile upper reference limit of the overall reference population is commonly used to diagnose myocardial infarction in clinical practice. This trial aims to determine whether the use of a lower female-specific hs-cTn threshold would improve the diagnosis, treatment, and outcomes of women presenting to the emergency department with symptoms suggestive of myocardial ischemia. METHODS/DESIGN: CODE-MI (hs-cTn-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women) is a multicenter, stepped-wedge, cluster-randomized trial of 30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital. All adults (≥20 years of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion. Over five, 5-month intervals, hospitals will be randomized to implement lower female hs-cTn thresholds according to the assay being used at each site. Men will continue to be assessed using the overall thresholds throughout. Women with a peak hs-cTn value between the female-specific and the overall thresholds will form our primary cohort. The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models. The cohort and outcomes will be obtained from routinely collected administrative data. The trial is designed to detect a 20% relative risk difference in the primary outcome, or a 2.2% absolute difference, with 82% power. CONCLUSIONS: This pragmatic trial will assess whether adopting lower female hs-cTn thresholds leads to appropriate assessment of women with symptoms suggestive of myocardial infarction, thereby improving treatment and outcomes.
Competing Interests: Disclosures CODE-MI is funded by: the Canadian Institutes for Health Research and in-kind contribution and unencumbered educational support for knowledge translation activities from Roche Diagnostics International, Ltd, and Beckman Coulter, Inc. P. K. has received grants/reagents/consultant/advisor/ honoraria from Abbott Laboratories, Abbott Point of Care, Abbott Diagnostics Division Canada, Beckman Coulter, Ortho Clinical Diagnostics, Randox Laboratories, Roche Diagnostics, and Siemens Healthcare Diagnostics and is listed as an inventor in patents in the acute cardiovascular biomarker field filed by McMaster University. N. L. M. reports research grants from Siemens Healthineers and Abbott Diagnostics to the University of Edinburgh and honoraria from Siemens Healthineers, Abbot Diagnostics, and Roche Diagnostics. J.A.U. is supported by a Heart and Stroke Foundation National New Investigator-Ontario Clinician Scientist Award and an Ontario Ministry of Research Innovation and Science Early Researcher Award, received personal fees for consulting for or honoraria from Amgen, AstraZeneca, Boehringer-Ingelheim, Janssen, Merck, Novartis and Sanofi and reports grant support to his institutions from AstraZeneca, Novartis and Sanofi.
(Copyright © 2020 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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