Yader Sandoval1, Stephen W Smith2, Sara A Love3, Anne Sexter4, Karen Schulz4, Fred S Apple5. 1. Division of Cardiology, Hennepin County Medical Center and Minneapolis Heart Institute, Abbott Northwestern Hospital, Minn. 2. Department of Emergency Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis. 3. Minneapolis Medical Research Foundation, Minn; Department of Laboratory Medicine and Pathology, Hennepin County Medical Center and University of Minnesota, Minneapolis. 4. Minneapolis Medical Research Foundation, Minn. 5. Minneapolis Medical Research Foundation, Minn; Department of Laboratory Medicine and Pathology, Hennepin County Medical Center and University of Minnesota, Minneapolis. Electronic address: apple004@umn.edu.
Abstract
BACKGROUND: This study examined the performance of single high-sensitivity cardiac troponin I (hs-cTnI) measurement strategies to rule out acute myocardial infarction. METHODS: This was a prospective, observational study of consecutive patients presenting to the emergency department (n = 1631) in whom cTnI measurements were obtained using an investigational hs-cTnI assay. The goals of the study were to determine 1) negative predictive value (NPV) and sensitivity for the diagnosis of acute myocardial infarction, type 1 myocardial infarction, and type 2 myocardial infarction; and 2) safety outcome of acute myocardial infarction or cardiac death at 30 days using hs-cTnI less than the limit of detection (LoD) (<1.9 ng/L) or the High-STEACS threshold (<5 ng/L) alone and in combination with normal electrocardiogram (ECG). RESULTS: Acute myocardial infarction occurred in 170 patients (10.4%), including 68 (4.2%) type 1 myocardial infarction and 102 (6.3%) type 2 myocardial infarction. For hs-cTnI<LoD (27%), the NPV and sensitivity for acute myocardial infarction were 99.6% (95% confidence interval 98.9%-100%) and 98.8 (97.2%-100%). For hs-cTnI<5 ng/L (50%), the NPV and sensitivity for acute myocardial infarction were 98.9% (98.2%-99.6%) and 94.7% (91.3%-98.1%). In combination with a normal ECG, 1) hs-cTnI<LoD had an NPV of 99.6% (98.9%-100%) and sensitivity of 99.4% (98.3%-100%); and 2) hs-cTnI<5 ng/L had an NPV of 99.5% (98.8%-100%) and sensitivity of 98.8% (97.2%-100%). The NPV and sensitivity for the safety outcome were excellent for hs-cTnI<LoD alone or in combination with a normal ECG, and for hs-cTnI<5 ng/L in combination with a normal ECG. CONCLUSION: Strategies using a single hs-cTnI alone or in combination with a normal ECG allow the immediate identification of patients unlikely to have acute myocardial infarction and who are at very low risk for adverse events at 30 days.
BACKGROUND: This study examined the performance of single high-sensitivity cardiac troponin I (hs-cTnI) measurement strategies to rule out acute myocardial infarction. METHODS: This was a prospective, observational study of consecutive patients presenting to the emergency department (n = 1631) in whom cTnI measurements were obtained using an investigational hs-cTnI assay. The goals of the study were to determine 1) negative predictive value (NPV) and sensitivity for the diagnosis of acute myocardial infarction, type 1 myocardial infarction, and type 2 myocardial infarction; and 2) safety outcome of acute myocardial infarction or cardiac death at 30 days using hs-cTnI less than the limit of detection (LoD) (<1.9 ng/L) or the High-STEACS threshold (<5 ng/L) alone and in combination with normal electrocardiogram (ECG). RESULTS:Acute myocardial infarction occurred in 170 patients (10.4%), including 68 (4.2%) type 1 myocardial infarction and 102 (6.3%) type 2 myocardial infarction. For hs-cTnI<LoD (27%), the NPV and sensitivity for acute myocardial infarction were 99.6% (95% confidence interval 98.9%-100%) and 98.8 (97.2%-100%). For hs-cTnI<5 ng/L (50%), the NPV and sensitivity for acute myocardial infarction were 98.9% (98.2%-99.6%) and 94.7% (91.3%-98.1%). In combination with a normal ECG, 1) hs-cTnI<LoD had an NPV of 99.6% (98.9%-100%) and sensitivity of 99.4% (98.3%-100%); and 2) hs-cTnI<5 ng/L had an NPV of 99.5% (98.8%-100%) and sensitivity of 98.8% (97.2%-100%). The NPV and sensitivity for the safety outcome were excellent for hs-cTnI<LoD alone or in combination with a normal ECG, and for hs-cTnI<5 ng/L in combination with a normal ECG. CONCLUSION: Strategies using a single hs-cTnI alone or in combination with a normal ECG allow the immediate identification of patients unlikely to have acute myocardial infarction and who are at very low risk for adverse events at 30 days.
Authors: Yader Sandoval; Bradley R Lewis; Ramila A Mehta; Olatunde Ola; Jonathan D Knott; Laura De Michieli; Ashok Akula; Ronstan Lobo; Eric H Yang; S Michael Gharacholou; Marshall Dworak; Erika Crockford; Nicholas Rastas; Eric Grube; Swetha Karturi; Scott Wohlrab; David O Hodge; Tahir Tak; Charles Cagin; Rajiv Gulati; Allan S Jaffe Journal: Circulation Date: 2022-05-10 Impact factor: 39.918
Authors: Ian Gunsolus; Yader Sandoval; Stephen W Smith; Anne Sexter; Karen Schulz; Charles A Herzog; Fred S Apple Journal: J Am Soc Nephrol Date: 2017-10-27 Impact factor: 10.121
Authors: Andrew R Chapman; Kuan Ken Lee; David A McAllister; Louise Cullen; Jaimi H Greenslade; William Parsonage; Andrew Worster; Peter A Kavsak; Stefan Blankenberg; Johannes Neumann; Nils A Sörensen; Dirk Westermann; Madelon M Buijs; Gerard J E Verdel; John W Pickering; Martin P Than; Raphael Twerenbold; Patrick Badertscher; Zaid Sabti; Christian Mueller; Atul Anand; Philip Adamson; Fiona E Strachan; Amy Ferry; Dennis Sandeman; Alasdair Gray; Richard Body; Brian Keevil; Edward Carlton; Kim Greaves; Frederick K Korley; Thomas S Metkus; Yader Sandoval; Fred S Apple; David E Newby; Anoop S V Shah; Nicholas L Mills Journal: JAMA Date: 2017-11-21 Impact factor: 56.272
Authors: Atul Anand; Kuan Ken Lee; Andrew R Chapman; Amy V Ferry; Phil D Adamson; Fiona E Strachan; Colin Berry; Iain Findlay; Anne Cruikshank; Alan Reid; Paul O Collinson; Fred S Apple; David A McAllister; Donogh Maguire; Keith A A Fox; David E Newby; Chris Tuck; Ronald Harkess; Catriona Keerie; Christopher J Weir; Richard A Parker; Alasdair Gray; Anoop S V Shah; Nicholas L Mills Journal: Circulation Date: 2021-03-23 Impact factor: 39.918
Authors: Mark Mariathas; Rick Allan; Sanjay Ramamoorthy; Bartosz Olechowski; Jonathan Hinton; Martin Azor; Zoe Nicholas; Alison Calver; Simon Corbett; Michael Mahmoudi; John Rawlins; Iain Simpson; James Wilkinson; Chun Shing Kwok; Paul Cook; Mamas A Mamas; Nick Curzen Journal: BMJ Date: 2019-03-13
Authors: R H Christenson; W F Peacock; F S Apple; A T Limkakeng; R M Nowak; J McCord; C R deFilippi Journal: Contemp Clin Trials Commun Date: 2019-02-15
Authors: Martin P Than; John W Pickering; Yader Sandoval; Anoop S V Shah; Athanasios Tsanas; Fred S Apple; Stefan Blankenberg; Louise Cullen; Christian Mueller; Johannes T Neumann; Raphael Twerenbold; Dirk Westermann; Agim Beshiri; Nicholas L Mills Journal: Circulation Date: 2019-08-16 Impact factor: 29.690
Authors: Anoop S V Shah; Yader Sandoval; Ala Noaman; Anne Sexter; Amar Vaswani; Stephen W Smith; Mathew Gibbins; Megan Griffiths; Andrew R Chapman; Fiona E Strachan; Atul Anand; Martin A Denvir; Philip D Adamson; Michelle S D'Souza; Alasdair J Gray; David A McAllister; David E Newby; Fred S Apple; Nicholas L Mills Journal: BMJ Date: 2017-11-07
Authors: James E Andruchow; Timothy Boyne; Grant Innes; Shabnam Vatanpour; Isolde Seiden-Long; Dongmei Wang; Eddy Lang; Andrew D McRae Journal: CJC Open Date: 2019-08-27