Dataset Information

Design and rationale of the high-sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial.

ABSTRACT: BACKGROUND:Acute 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. METHODS:The 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. CONCLUSION:TACIT 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.

SUBMITTER: Hunter BR

PROVIDER: S-EPMC5441668 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Design and rationale of the high-sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial.

Hunter Benton R BR Collins Sean P SP Fermann Gregory J GJ Levy Phillip D PD Shen Changyu C Ayaz Syed Imran SI Cole Mette L ML Miller Karen F KF Soliman Adam A AA Pang Peter S PS

Pragmatic and observational research 20170518

<h4>Background</h4>Acute 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.<h4>Methods</h4>The highly sensitive Troponin T Rules Out Acute Cardiac Insufficiency Trial (TACIT) will enroll ED patients being treated for AHF. Patients will undergo standard E ...[more]

PMID: 28572743

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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.

Project description:BackgroundWe aimed to prospectively validate a novel 1-hour algorithm using high-sensitivity cardiac troponin T measurement for early rule-out and rule-in of acute myocardial infarction (MI).MethodsIn a multicentre study, we enrolled 1320 patients presenting to the emergency department with suspected acute MI. The high-sensitivity cardiac troponin T 1-hour algorithm, incorporating baseline values as well as absolute changes within the first hour, was validated against the final diagnosis. The final diagnosis was then adjudicated by 2 independent cardiologists using all available information, including coronary angiography, echocardiography, follow-up data and serial measurements of high-sensitivity cardiac troponin T levels.ResultsAcute MI was the final diagnosis in 17.3% of patients. With application of the high-sensitivity cardiac troponin T 1-hour algorithm, 786 (59.5%) patients were classified as "rule-out," 216 (16.4%) were classified as "rule-in" and 318 (24.1%) were classified to the "observational zone." The sensitivity and the negative predictive value for acute MI in the rule-out zone were 99.6% (95% confidence interval [CI] 97.6%-99.9%) and 99.9% (95% CI 99.3%-100%), respectively. The specificity and the positive predictive value for acute MI in the rule-in zone were 95.7% (95% CI 94.3%-96.8%) and 78.2% (95% CI 72.1%-83.6%), respectively. The 1-hour algorithm provided higher negative and positive predictive values than the standard interpretation of highsensitivity cardiac troponin T using a single cut-off level (both p < 0.05). Cumulative 30-day mortality was 0.0%, 1.6% and 1.9% in patients classified in the rule-out, observational and rule-in groups, respectively (p = 0.001).InterpretationThis rapid strategy incorporating high-sensitivity cardiac troponin T baseline values and absolute changes within the first hour substantially accelerated the management of suspected acute MI by allowing safe rule-out as well as accurate rule-in of acute MI in 3 out of 4 patients.Trial registrationClinicalTrials.gov, NCT00470587.

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.

Dataset Information

Design and rationale of the high-sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial.

Publications

Design and rationale of the high-sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial.

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