Use of High-Sensitivity Cardiac Troponin in Patients With Kidney Impairment: A Randomized Clinical Trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Gallacher PJ
PROVIDER: S-EPMC8185626 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BACKGROUND:Identifying low-risk acute heart failure patients safe for discharge from the emergency department is a major unmet need. METHODS AND RESULTS:A prospective, observational, multicenter pilot study targeting lower risk acute heart failure patients to determine whether hsTnT (high-sensitivity troponin T) identifies emergency department acute heart failure patients at low risk for rehospitalization and mortality. hsTnT was drawn at baseline and 3 hours. Phone follow-up occurred at 30 and 90 days. The primary end point composite of all-cause mortality, rehospitalization, and emergency department visits at 90 days (changed from 30 days because of lack of mortality events), analyzed using logistic regression. Secondary end points: 30- and 90-day all-cause mortality. hsTnT values less than the 99th percentile were defined as low hsTnT. Out of 527 enrolled patients, 499 comprised the initial analysis set. Of these, 332 had both 0- and 3-hour hsTnT drawn, of whom 319 completed 30 day follow-up. The average age was 62, 60% male, and 57% black. Median hsTnT was 26.4 ng/L (interquartile range, 15.1-44.3). There were 99 (21%) 30-day composite events, 13 (2.7%) deaths at 30 days, and 25 deaths (8.2%) at 90 days. Serial hsTnT values below the 99th percentile were not associated with a lower risk for the 90-day primary composite end point (odds ratio, 0.79; 95% CI, 0.42-1.50; P=0.4736). However, no deaths occurred in the low hsTnT group at 30 days with 1 death at 90 days. CONCLUSIONS:hsTnT did not identify patients at low risk for the primary outcome of rehospitalization, emergency department visits, and mortality at 90 days. CLINICAL TRIAL REGISTRATION:URL: https://www.clinicaltrials.gov . Unique identifier: NCT02592135.
| S-EPMC6719714 | biostudies-literature
Project description:ImportanceThe clinical implications of high-sensitivity cardiac troponin T (hs-cTnT) measurements in patients with acute kidney injury (AKI) in the emergency department (ED) are largely unknown.ObjectivesTo investigate associations between serum creatinine (SCr) concentrations and hs-cTnT kinetics, as well as the clinical accuracy of hs-cTnT for myocardial infarction (MI) in patients with AKI.Design, setting, and participantsThis retrospective cohort study included 15 111 patient visits to 7 EDs in Sweden from December 9, 2010, to August 31, 2017, by patients 18 years or older fulfilling AKI criteria with 2 or more SCr measurements and 1 or more hs-cTnT measurement. Statistical analysis was performed from October 2, 2022, to September 28, 2023.ExposureDynamic change in SCr during the ED visits.Main outcomes and measuresLinear mixed-effects models were used to estimate the log-linear regression of kinetic change in hs-cTnT. Logistic regression models were applied to calculate odds ratios (ORs) for change in hs-cTnT indicating acute myocardial injury (Δhs-cTnT >20% and elevated hs-cTnT >14 ng/L) in association with change in SCr, and to assess the diagnostic performance of hs-cTnT for MI in patients with chest pain.ResultsThere was a total of 15 211 visits by 13 638 patients (median age, 74 years [IQR, 64-83 years]; 8709 men [57%]), of whom 1174 (8%) had an MI. Overall, 11 353 of patients at 14 037 visits without an MI diagnosis (81%) had myocardial injury, and 4396 patients at 14 037 visits (31%) had acute myocardial injury. The change in hs-cTnT among patients without MI was 1.8-fold higher in the highest vs the lowest change in SCr quartile (64.7% [95% CI, 58.4%-71.5%] vs 36.3% [95% CI, 32.4%-40.7%]; exponentiated β coefficient, 1.78 [95% CI, 1.62-1.96]). Patients in the former group were twice as likely to have acute myocardial injury (39% [1378 of 3516 visits] vs 23% [817 of 3507 visits]; adjusted OR, 2.32 [95% CI, 2.08-2.59]). Using a 0 hours hs-cTnT cutoff value of 52 ng/L or higher assigned 627 of 2388 patients (26%) with chest pain to a high-risk group in whom the specificity and positive predictive value for MI was low (78.5% [95% CI, 76.7%-80.2&] and 27.6% [95% CI, 24.1%-31.3%], respectively).Conclusions and relevanceThis cohort study of patients in the ED suggests that dynamic change in SCr among patients with AKI was associated with hs-cTnT concentrations indicative of acute myocardial injury. These observations were accompanied by poor performance of recommended hs-cTnT-based algorithms for MI risk stratification.
| S-EPMC11365000 | biostudies-literature
Project description:BackgroundHigh-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early rule-out pathway is safe and effective for patients with suspected acute coronary syndrome.MethodsWe performed a stepped-wedge cluster randomized controlled trial in the emergency departments of 7 acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a previous validation phase, myocardial infarction was ruled out when troponin concentrations were <99th percentile at 6 to 12 hours after symptom onset. The coprimary outcome was length of stay (efficacy) and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes.ResultsWe enrolled 31 492 patients (59±17 years of age [mean±SD]; 45% women) with troponin concentrations <99th percentile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio, 0.78 [95% CI, 0.73-0.83]; P<0.001) after implementation and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio, 1.59 [95% CI, 1.45-1.75]). Noninferiority was not demonstrated for the 30-day safety outcome (upper limit of 1-sided 95% CI for adjusted risk difference, 0.70% [noninferiority margin 0.50%]; P=0.068), but the observed differences favored the early rule-out pathway (0.4% [57/14 700] versus 0.3% [56/16 792]). At 1 year, the safety outcome occurred in 2.7% (396/14 700) and 1.8% (307/16 792) of patients before and after implementation (adjusted odds ratio, 1.02 [95% CI, 0.74-1.40]; P=0.894), and there were no differences in hospital reattendance or all-cause mortality.ConclusionsImplementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Although noninferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and health care providers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.
| S-EPMC8177493 | biostudies-literature
Project description:Study objectiveOur objective is to describe the rates of diagnostic reclassification between conventional cardiac troponin I (cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) and between combined and sex-specific hs-cTnT thresholds in adult emergency department (ED) patients in the United States.MethodsWe conducted a prospective, single-center, before-and-after, observational study of ED patients aged 18 years or older undergoing single or serial cardiac troponin testing in the ED for any reason before and after hs-cTnT implementation. Conventional cTnI and hs-cTnT results were obtained from a laboratory quality assurance database. Combined and sex-specific thresholds were the published 99th percentile upper reference limits for each assay. Cases underwent physician adjudication using the Fourth Universal Definition of Myocardial Infarction. Diagnostic reclassification occurred when a patient received a diagnosis of myocardial infarction or myocardial injury with one assay but not the other assay. Our primary outcome was diagnostic reclassification between the conventional cTnI and hs-cTnT assays. Diagnostic reclassification probabilities were assessed with sample proportions and 95% confidence intervals for binomial data.ResultsWe studied 1,016 patients (506 men [50%]; median age 60 years [25th, 75th percentiles 49, 71]). Between the conventional cTnI and hs-cTnT assays, 6 patients (0.6%; 95% confidence interval 0.2% to 1.3%) underwent diagnostic reclassification regarding myocardial infarction (5/6 reclassified as no myocardial infarction) and 166 patients (16%; 95% confidence interval 14% to 19%) underwent diagnostic reclassification regarding myocardial injury (154/166 reclassified as having myocardial injury) by hs-cTnT.ConclusionCompared with conventional cTnI, the hs-cTnT assay resulted in no clinically relevant change in myocardial infarction diagnoses but substantially more myocardial injury diagnoses.
| S-EPMC7606506 | biostudies-literature
Project description:BackgroundThe diagnosis of hypertension is often preceded by cardiac structural abnormalities. Thus, we assessed whether high-sensitivity cardiac troponin T (hs-cTnT), a marker of subclinical myocardial damage, can identify individuals at risk for hypertension or left ventricular hypertrophy.Methods and resultsWe studied 6516 Atherosclerosis Risk in Communities (ARIC) Study participants who were free of prevalent hypertension and cardiovascular disease at baseline (1990-1992). We examined the association of baseline hs-cTnT categories with incident diagnosed hypertension (defined by self-report of a diagnosis or medication use during a maximum of 19.9 years of follow-up) and with incident visit-based hypertension (defined by self-report, medication use, or measured blood pressure >140/90 mm Hg over 6 years). Relative to hs-cTnT <5 ng/L, adjusted hazard ratios for incident diagnosed hypertension were 1.16 (95% confidence interval, 1.08-1.25) for individuals with hs-cTnT of 5 to 8 ng/L, 1.29 (95% confidence interval, 1.14-1.47) for hs-cTnT of 9 to 13 ng/L, and 1.31 (95% confidence interval, 1.07-1.61) for hs-cTnT ≥14 ng/L (P for trend <0.001). Associations were stronger for incident visit-based hypertension. These associations were driven by higher relative hazard in normotensive people (compared with those with prehypertension; P for interaction=0.001). Baseline hs-cTnT was also strongly associated with incident left ventricular hypertrophy by electrocardiography over 6 years (eg, adjusted hazard ratio, 5.19 [95% confidence interval, 1.49-18.08] for hs-cTnT ≥14 versus <5 ng/L). Findings were not appreciably changed after accounting for competing deaths or adjusting for baseline blood pressure levels or N-terminal probrain natriuretic peptide.ConclusionsIn an ambulatory population with no history of cardiovascular disease, hs-cTnT was associated with incident hypertension and risk of left ventricular hypertrophy. Further research is needed to determine whether hs-cTnT can identify people who may benefit from ambulatory blood pressure monitoring or hypertension prevention lifestyle strategies.
| S-EPMC4558242 | biostudies-literature
Project description:ObjectiveIn patients with acute chest pain who have had myocardial infarction excluded, plasma cardiac troponin I concentrations ≥5 ng/L are associated with risk of future adverse cardiovascular events. We aim to evaluate the association between cardiac troponin and coronary plaque composition in such patients.MethodsIn a prespecified secondary analysis of a prospective cohort study, blinded quantitative plaque analysis was performed on 242 CT coronary angiograms of patients with acute chest pain in whom myocardial infarction was excluded. Patients were stratified by peak plasma cardiac troponin I concentration ≥5 ng/L or <5 ng/L. Associations were assessed using univariable and multivariable logistic regression analyses.ResultsThe cohort was predominantly middle-aged (62±12 years) men (69%). Patients with plasma cardiac troponin I concentration ≥5 ng/L (n=161) had a higher total (median 33% (IQR 0-47) vs 0% (IQR 0-33)), non-calcified (27% (IQR 0-37) vs 0% (IQR 0-28)), calcified (2% (IQR 0-8) vs 0% (IQR 0-3)) and low-attenuation (1% (IQR 0-3) vs 0% (IQR 0-1)) coronary plaque burden compared with those with concentrations <5 ng/L (n=81; p≤0.001 for all). Low-attenuation plaque burden was independently associated with plasma cardiac troponin I concentration ≥5 ng/L after adjustment for clinical characteristics (adjusted OR per doubling 1.62 (95% CI 1.17 to 2.32), p=0.005) or presence of any visible coronary artery disease (adjusted OR per doubling 1.57 (95% CI 1.07 to 2.37), p=0.026).ConclusionIn patients with acute chest pain but without myocardial infarction, plasma cardiac troponin I concentrations ≥5 ng/L are associated with greater burden of low-attenuation coronary plaque.
| S-EPMC10357930 | biostudies-literature
Project description:BackgroundAcute heart failure (AHF) is a common presentation in the Emergency Department (ED), and most patients are admitted to the hospital. Identification of patients with AHF who have a low risk of adverse events and are suitable for discharge from the ED is difficult, and an objective tool would be useful.MethodsThe highly sensitive Troponin T Rules Out Acute Cardiac Insufficiency Trial (TACIT) will enroll ED patients being treated for AHF. Patients will undergo standard ED evaluation and treatment. High-sensitivity troponin T (hsTnT) will be drawn at the time of enrollment and 3 hours after the initial draw. The initial hsTnT draw will be no more than 3 hours after initiation of therapy for AHF (vasodilator, loop diuretic, noninvasive ventilation). Treating clinicians will be blinded to hsTnT results. We will assess whether hsTnT, as a single measurement or in series, can accurately predict patients at low risk of short-term adverse events.ConclusionTACIT will explore the value of hsTnT measurements in isolation, or in combination with other markers of disease severity, for the identification of ED patients with AHF who are at low risk of short-term adverse events.
| S-EPMC5441668 | biostudies-literature
Project description:BackgroundFew data compare cardiac troponin T (cTnT) and cardiac troponin I (cTnI) in a general population. We sought to evaluate the distribution and association between cTnT, cTnI, and cardiovascular risk factors in a large general population cohort.MethodsHigh-sensitivity cTnT and cTnI were measured in serum from 19501 individuals in the Generation Scotland Scottish Family Health Study. Associations with cardiovascular risk factors were compared using age- and sex-adjusted regression. Observed age- and sex-stratified 99th centiles were compared with 99th centiles for cTnT (men, 15.5 ng/L; women, 9.0 ng/L) and cTnI (men, 34.2 ng/L; women, 15.6 ng/L) used in clinical practice.ResultscTnT and cTnI concentrations were detectable in 53.3% and 74.8% of participants, respectively, and were modestly correlated in unadjusted analyses (R 2 = 21.3%) and only weakly correlated after adjusting for age and sex (R 2 = 9.5%). Cardiovascular risk factors were associated with both troponins, but in age- and sex-adjusted analyses, cTnI was more strongly associated with age, male sex, body mass index, and systolic blood pressure (P < 0.0001 for all vs cTnT). cTnT was more strongly associated with diabetes (P < 0.0001 vs cTnI). The observed 99th centiles were broadly consistent with recommended 99th centiles in younger men and women. After the age of 60 years, observed 99th centiles increased substantially for cTnT, and beyond 70 years of age, the 99th centiles approximately doubled for both troponins.ConclusionsIn the general population, cTnT and cTnI concentrations are weakly correlated and are differentially associated with cardiovascular risk factors. The 99th centiles currently in use are broadly appropriate for men and women up to but not beyond the age of 60 years.
| S-EPMC6398571 | biostudies-literature
Project description:(1) Background: Patients with severe chronic kidney disease (CKD G4-G5) often have chronically elevated high-sensitivity cardiac troponin T (hs-cTnT) values above the 99th percentile of the upper reference limit. In these patients, optimal cutoff levels for diagnosing non-ST-elevation acute coronary syndrome (NSTE-ACS) requiring revascularization remain undefined. (2) Methods: Of 11,912 patients undergoing coronary angiography from 2012 to 2017 for suspected NSTE-ACS, 325 (3%) had severe CKD. Of these, 290 with available serial hs-cTnT measurements were included, and 300 matched patients with normal renal function were selected as a control cohort. (3) Results: In the CKD cohort, 222 patients (76%) had NSTE-ACS with indication for coronary revascularization. Diagnostic performance was high at presentation and similar to that of the control population (AUC, 95% CI: 0.81, 0.75-0.87 versus 0.85, 0.80-0.89, p = 0.68), and the ROC-derived cutoff value was 4 times higher compared to the conventional 99th percentile. Combining the ROC-derived cutoff levels for hs-cTnT at presentation and absolute 3 h changes, sensitivity increased to 98%, and PPV and NPV improved up to 93% and 86%, respectively. (4) Conclusions: In patients with severe CKD and suspected ACS, the diagnostic accuracy of hs-cTnT for the diagnosis of NSTE-ACS requiring revascularization is improved by using higher assay-specific cutoff levels combined with early absolute changes.
| S-EPMC8471888 | biostudies-literature
Project description:BackgroundHigh-sensitivity cardiac troponin I (hs-cTnI) assays have been developed that quantify lower cTnI concentrations with better precision versus earlier generation assays. hs-cTnI assays allow improved clinical utility for diagnosis and risk stratification in patients presenting to the emergency department with suspected acute myocardial infarction. We describe the High-Sensitivity Cardiac Troponin I Assays in the United States (HIGH-US) study design used to conduct studies for characterizing the analytical and clinical performance of hs-cTnI assays, as required by the US Food and Drug Administration for a 510(k) clearance application. This study was non-interventional and therefore it was not registered at clinicaltrials.gov.MethodsWe conducted analytic studies utilizing Clinical and Laboratory Standards Institute guidance that included limit of blank, limit of detection, limit of quantitation, linearity, within-run and between run imprecision and reproducibility as well as potential interferences and high dose hook effect. A sample set collected from healthy females and males was used to determine the overall and sex-specific cTnI 99th percentile upper reference limits (URL). The total coefficient of variation at the female 99th percentile URL and a universally available American Association for Clinical Chemistry sample set (AACC Universal Sample Bank) from healthy females and males was used to examine high-sensitivity (hs) performance of the cTnI assays. Clinical diagnosis of enrolled subjects was adjudicated by expert cardiologists and emergency medicine physicians. Assessment of temporal diagnostic accuracy including sensitivity, specificity, positive predictive value, and negative predictive value were determined at presentation and collection times thereafter. The prognostic performance at one-year after presentation to the emergency department was also performed. This design is appropriate to describe analytical characterization and clinical performance, and allows for acute myocardial infarction diagnosis and risk assessment.
| S-EPMC6384326 | biostudies-literature