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Clin Exp Emerg Med > Accepted Articles
doi: https://doi.org/10.15441/ceem.24.294    [Accepted]
A rapid noninvasive wearable device for assessing cardiac troponin level
William Franklin Peacock1, Karina Melissa Soto-Ruiz2, Allan S. Jaffe3, Brian R. Tiffany4, Simon A. Mahler5,6,7, Brian W. Patterson8, Alan H. B. Wu9, Robert Christenson10
1Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA
2Comprehensive Research Associates LLC, Houston, TX, USA
3Department of Cardiology, Mayo Clinic, Rochester, MN, USA
4Department of Emergency Medicine, Chandler Regional Medical Center, Chandler, AZ, USA
5Department of Emergency Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA
6Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA
7Department of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA
8Berbee Walsh Department of Emergency Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
9Department of Laboratory Medicine, University of California, San Francisco, CA, USA
10Department of Laboratory Medicine, University of Maryland, Baltimore, MD, USA
Correspondence  William Franklin Peacock Tel: (216) 312-3292, Email: Frankpeacock@gmail.com
Received: July 28, 2024. Revised: August 17, 2024.  Accepted: August 18, 2024. Published online: September 6, 2024.
ABSTRACT
Objective
Chest pain, a common emergency department presentation, requires rapid evaluation. The current gold standard of care is serial troponin measurements from blood draws along with an electrocardiogram and clinical presentation. However, an optical technology-based noninvasive wearable device, the Infrasensor, which can rapidly and transcutaneously assesses cardiac troponin I (cTnI), was recently developed. We aimed to perform a pilot study to evaluate the performance of the Infrasensor in cTnI defined cohorts.
Methods
This was a 10-hospital prospective observational study in healthy US subjects with a normal cTnI level and in patients with an elevated local cTnI level. Healthy subjects as determined by a negative questionnaire and bloodwork underwent 3-minute Infrasensor measurement and levels of high-sensitivity cTnI (hs-cTnI), n-terminal pro-B-type natriuretic peptide (NTproBNP), creatinine, and glycosylated hemoglobin (HbA1c) were evaluated from blood. Patients with elevated cTnI had the same Infrasensor and blood sample measurements. Using a fivefold cross-validation technique, cTnI-based binary classification models that did and did not include age were trained on 80% and validated on 20% of the dataset (n=168; elevated hs-cTnI equally partitioned into five nearly equally-sized subsets ).
Result
s: Of 840 patients, 727 (87.5%) had normal (nonelevated) cTnI levels while the remaining 113 had elevated cTnI. Median age was 61 years (interquartile range, 52–71 years) for the elevated cohort and 48 years (interquartile range, 32–57 years) for the nonelevated. Overall, 416 (50.5%) were female, with 33 of 113 (29.2%) in the elevated cohort and 383 of 727 (52.7%) in the nonelevated cohort. Overall, the sensitivity, specificity, negative and positive predictive values of the Infrasensor for identifying elevated cTnI were 0.90, 0.70, 0.98 and 0.48, respectively, with a C-statistic of 0.90 (95% confidence interval, 0.89–0.99).
Conclusion
The Infrasensor accurately identifies elevated cTnI within 3 minutes of application.
Keywords: Troponin; Acute coronary syndrome; Acute myocardial infarction; Risk stratification
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