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1.
  • Borna, Catharina, et al. (författare)
  • The objective CORE score allows early rule out in acute chest pain patients
  • 2018
  • Ingår i: Scandinavian Cardiovascular Journal. - : Informa UK Limited. - 1401-7431 .- 1651-2006. ; 52:6, s. 308-314
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives. Chest pain is a common complaint in the emergency department (ED), and it is a challenge to identify low-risk chest pain patients eligible for early discharge. We aimed to develop a simple objective decision rule to exclude 30-day major adverse cardiac events (MACE) in ED chest pain patients. Design. We analyzed prospectively included patients presenting with chest pain. Low risk patients were identified with the clinical objective rule-out evaluation (CORE). CORE was based on high sensitivity cardiac troponin T (hs-cTnT) tests at ED presentation (0 h) and 2 h later together with a simplified risk score consisting of four objective variables: age ≥65 years and a history of arterial disease, hypertension or diabetes. For the patient to be classified as low risk in the CORE rule, hs-cTnT had to be ≤14 ng/L both at 0 and 2 h, and the sum of the risk score had to be 0. The primary outcome was MACE within 30 days. Results. Among the 751 patients in the final analysis, 90 (11.9%) had a MACE. CORE identified 248 (33%) of patients as low risk with a sensitivity of 98.9% (CI 93.1–99.9) and a negative predictive value of 99.6% (95% CI 97.4–100) for 30-day MACE. Adding the ED physician’s interpretation of the ECG to CORE did not improve diagnostic performance. Conclusion. A simple objective decision rule (CORE) identified one-third of all patients as having a very low 30-day risk of MACE. These patients may potentially be discharged without additional investigations for acute coronary syndrome.
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  • Ederoth, Per, et al. (författare)
  • Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS) : A study protocol for a double-blind, randomised, placebo-controlled, proof-of-concept study
  • 2016
  • Ingår i: BMJ Open. - 2044-6055. ; 6:12
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: Acute kidney injury (AKI) after cardiac surgery is common and results in increased morbidity and mortality. One possible mechanism for AKI is ischaemia-reperfusion injury caused by the extracorporeal circulation (ECC), resulting in an opening of the mitochondrial permeability transition pore (mPTP) in the kidneys, which can lead to cell injury or cell death. Ciclosporin may block the opening of mPTP if administered before the ischaemia- reperfusion injury. We hypothesised that ciclosporin given before the start of ECC in cardiac surgery can decrease the degree of AKI. Methods and analysis: Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS) study is an investigator-initiated double-blind, randomised, placebo-controlled, parallel design, single-centre study performed at a tertiary university hospital. The primary objective is to assess the safety and efficacy of ciclosporin to limit the degree of AKI in patients undergoing coronary artery bypass grafting surgery. We aim to evaluate 150 patients with a preoperative estimated glomerular filtration rate of 15-90 mL/min/ 1.73 m2. Study patients are randomised in a 1:1 ratio to receive study drug 2.5 mg/kg ciclosporin or placebo as an intravenous injection after anaesthesia induction but before start of surgery. The primary end point consists of relative P-cystatin C changes from the preoperative day to postoperative day 3. The primary variable will be tested using an analysis of covariance method. Secondary end points include evaluation of P-creatinine and biomarkers of kidney, heart and brain injury. Ethics and dissemination: The trial is conducted in compliance with the current version of the Declaration of Helsinki and the International Council for Harmonisation (ICH) Good Clinical Practice guidelines E6 (R1) and was approved by the Regional Ethical Review Board, Lund and the Swedish Medical Products Agency (MPA). Written and oral informed consent is obtained before enrolment into the study.
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  • Khoshnood, Ardavan, et al. (författare)
  • Effect of oxygen therapy on chest pain in patients with ST elevation myocardial infarction : results from the randomized SOCCER trial
  • 2018
  • Ingår i: Scandinavian Cardiovascular Journal. - : Informa UK Limited. - 1401-7431 .- 1651-2006. ; 52:2, s. 69-73
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective. Oxygen (O2) have been a cornerstone in the treatment of acute myocardial infarction. Studies have been inconclusive regarding the cardiovascular and analgesic effects of oxygen in these patients. In the SOCCER trial, we compared the effects of oxygen treatment versus room air in patients with ST-elevation myocardial infarction (STEMI). There was no difference in myocardial salvage index or infarct size assessed with cardiac magnetic resonance imaging. In the present subanalysis, we wanted to evaluate the effect of O2 on chest pain in patients with STEMI. Design. Normoxic patients with first time STEMI were randomized in the ambulance to standard care with 10 l/min O2 or room air until the end of the percutaneous coronary intervention (PCI). The ambulance personnel noted the patients´ chest pain on a visual analog scale (VAS; 1-10) before randomization and after the transport but before the start of the PCI, and also registered the amount of morphine given. Results. 160 patients were randomized to O2 (n = 85) or room air (n = 75). The O2 group had a higher median VAS at randomization than the air group (7.0 ± 2.3 vs 6.0 ± 2.9; p = .02) and also received a higher median total dose of morphine (5.0 mg ± 4.4 vs 4.0 mg ± 3.7; p = .02). There was no difference between the O2 and air groups in VAS at the start of the PCI (4.0 ± 2.4 vs 3.0 ± 2.5; p = .05) or in the median VAS decrease from randomization to the start of the PCI (−2.0 ± 2.2 vs −1.0 ± 2.9; p = .18). Conclusion. Taken together with previously published data, these results do not support a significant analgesic effect of oxygen in patients with STEMI. European Clinical Trials Database (EudraCT): 2011-001452-11. ClinicalTrials.gov Identifier: NCT01423929
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  • Khoshnood, Ardavan, et al. (författare)
  • Effect of oxygen therapy on myocardial salvage in ST elevation myocardial infarction : the randomized SOCCER trial
  • 2018
  • Ingår i: European Journal of Emergency Medicine. - 0969-9546. ; 25:2, s. 78-84
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: Recent studies suggest that administration of O2 in patients with acute myocardial infarction may have negative effects. With the use of cardiac MRI (CMR), we evaluated the effects of supplemental O2 in patients with ST elevation myocardial infarction (STEMI) accepted for acute percutaneous coronary intervention (PCI).MATERIALS AND METHODS: This study was a randomized-controlled trial conducted at two university hospitals in Sweden. Normoxic STEMI patients were randomized in the ambulance to either supplemental O2 (10 l/min) or room air until the conclusion of the PCI. CMR was performed 2-6 days after the inclusion. The primary endpoint was the myocardial salvage index assessed by CMR. The secondary endpoints included infarct size and myocardium at risk.RESULTS: At inclusion, the O2 (n=46) and air (n=49) patient groups had similar patient characteristics. There were no significant differences in myocardial salvage index [53.9±25.1 vs. 49.3±24.0%; 95% confidence interval (CI): -5.4 to 14.6], myocardium at risk (31.9±10.0% of the left ventricle in the O2 group vs. 30.0±11.8% in the air group; 95% CI: -2.6 to 6.3), or infarct size (15.6±10.4% of the left ventricle vs. 16.0±11.0%; 95% CI: -4.7 to 4.1).CONCLUSION: In STEMI patients undergoing acute PCI, we found no effect of high-flow oxygen compared with room air on the size of ischemia before PCI, myocardial salvage, or the resulting infarct size. These results support the safety of withholding supplemental oxygen in normoxic STEMI patients.
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  • Khoshnood, Ardavan, et al. (författare)
  • Effects of oxygen therapy on wall-motion score index in patients with ST elevation myocardial infarction-the randomized SOCCER trial
  • 2017
  • Ingår i: Echocardiography. - : Wiley. - 0742-2822. ; 34:8, s. 1130-1137
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Although oxygen (O2) is routinely used in patients with acute myocardial infarction (AMI), it may have negative effects. In this substudy of the SOCCER trial, we aimed to evaluate the effects of O2-treatment on myocardial function in patients with ST elevation myocardial infarction (STEMI). Methods: Normoxic (≥94%) STEMI patients were randomized in the ambulance to either supplemental O2 or room air until the end of the percutaneous coronary intervention (PCI). The patients underwent echocardiography on day 2-3 after the PCI and once again after 6 months. The study endpoints were wall-motion score index (WMSI) and left ventricular ejection fraction (LVEF). Results: Forty-six patients in the O2 group and 41 in the air group were included in the analysis. The index echocardiography showed no significant differences between the groups in WMSI (1.32±0.27 for O2 group vs 1.28±0.28 for air group) or LVEF (47.0±8.5% vs 49.2±8.1%). Nor were there differences at 6 months in WMSI (1.16±0.25 vs 1.14±0.24) or LVEF (53.5±5.8% vs 53.5±6.9%). Conclusion: The present findings indicate no harm or benefit of supplemental O2 on myocardial function in STEMI patients. Our results support that it is safe to withhold supplemental O2 in normoxic STEMI patients.
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  • Mokhtari, Arash, et al. (författare)
  • A 0-Hour/1-Hour Protocol for Safe, Early Discharge of Chest Pain Patients
  • 2017
  • Ingår i: Academic Emergency Medicine. - : Wiley. - 1069-6563 .- 1553-2712. ; 24:8, s. 983-992
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: Guidelines recommend a 0-hour/1-hour high-sensitivity cardiac troponin T (hs-cTnT) diagnostic strategy in acute chest pain patients. There are, however, little data on the performance of this strategy when combined with clinical risk stratification. We aimed to evaluate the diagnostic accuracy of an accelerated diagnostic protocol (ADP) using the 0-hour/1-hour hs-cTnT strategy together with an adapted Thrombolysis In Myocardial Infarction (TIMI) score and electrocardiogram (ECG) for ruling out major adverse cardiac events (MACE) within 30 days. Methods: This prospective observational study enrolled consecutive emergency department (ED) chest pain patients. TIMI score variables, ED physicians’ assessments of the ECG, and 0- and 1-hour hs-cTnT were collected. Thirty-day MACE was defined as acute myocardial infarction (AMI), unstable angina (UA), cardiogenic shock, ventricular arrhythmia, atrioventricular block, cardiac arrest, or death of cardiac or unknown cause. Results: A total of 1,020 patients were included in the final analysis. The combination of an adapted TIMI score ≤1, a nonischemic ECG, and either a 0-hour hs-cTnT < 5 ng/L or a 0-hour hs-cTnT < 12 ng/L combined with a 1-hour increase < 3 ng/L identified 432 (42.4%) patients as very low risk with a negative predictive value of 99.5% (95% confidence interval [CI] = 98.3%–99.9%) and a negative likelihood ratio of 0.04 (95% CI = 0.01–0.14) for 30-day MACE. The ADP missed only two patients with UA and no patients with AMI or other forms of MACE. Conclusion: An ADP using the guideline recommended 0-hour/1-hour hs-cTnT strategy rapidly identified patients with a very low risk of 30-day MACE including UA where no further cardiac testing would be needed. This could potentially allow safe early discharge of about 40% of ED chest pain patients.
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  • MOKHTARI, ARASH, et al. (författare)
  • A 1-h Combination Algorithm Allows Fast Rule-Out and Rule-In of Major Adverse Cardiac Events
  • 2016
  • Ingår i: Journal of the American College of Cardiology. - : Elsevier BV. - 0735-1097 .- 1558-3597. ; 67:13, s. 1531-1540
  • Tidskriftsartikel (refereegranskat)abstract
    • Background A 1-h algorithm based on high-sensitivity cardiac troponin T (hs-cTnT) testing at presentation and again 1 h thereafter has been shown to accurately rule out acute myocardial infarction. Objectives The goal of the study was to evaluate the diagnostic accuracy of the 1-h algorithm when supplemented with patient history and an electrocardiogram (ECG) (the extended algorithm) for predicting 30-day major adverse cardiac events (MACE) and to compare it with the algorithm using hs-cTnT alone (the troponin algorithm). Methods This prospective observational study enrolled consecutive patients presenting to the emergency department (ED) with chest pain, for whom hs-cTnT testing was ordered at presentation. Hs-cTnT results at 1 h and the ED physician’s assessments of patient history and ECG were collected. The primary outcome was an adjudicated diagnosis of 30-day MACE defined as acute myocardial infarction, unstable angina, cardiogenic shock, ventricular arrhythmia, atrioventricular block, cardiac arrest, or death of a cardiac or unknown cause. Results In the final analysis, 1,038 patients were included. The extended algorithm identified 60% of all patients for rule-out and had a higher sensitivity than the troponin algorithm (97.5% vs. 87.6%; p < 0.001). The negative predictive value was 99.5% and the likelihood ratio was 0.04 with the extended algorithm versus 97.8% and 0.17, respectively, with the troponin algorithm. The extended algorithm ruled-in 14% of patients with a higher sensitivity (75.2% vs. 56.2%; p < 0.001) but a slightly lower specificity (94.0% vs. 96.4%; p < 0.001) than the troponin algorithm. The rule-in arms of both algorithms had a likelihood ratio >10. Conclusions A 1-h combination algorithm allowed fast rule-out and rule-in of 30-day MACE in a majority of ED patients with chest pain and performed better than the troponin-alone algorithm.
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  • Mokhtari, Arash, et al. (författare)
  • A multicenter evaluation of the safety and effectiveness of a 0h/1h protocol in the assessment of emergency department chest pain patients.
  • 2018
  • Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
    • BackgroundIn emergency department (ED) chest pain patients, the European Society of Cardiology recommends the use of a 0h/1h high-sensitivity cardiac Troponin (hs-cTn) protocol. However, the recommendation is based on observational studies and the effects of the protocol when implemented in routine care is unknown. The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine careMethodsIn this before-and-after implementation study with concurrent controls, all patients ≥18 years with a chief complaint of non-traumatic chest pain and possible acute coronary syndrome (ACS) will be included at the EDs of Skåne University Hospital at Lund and Malmö, Helsingborg Hospital, Ystad Hospital and Kristianstad Hospital in southern Sweden. Patients with STEMI, patients leaving against medical advice and non-Swedish residents will be excluded. The 0h/1h protocol identifies low-risk patients suitable for early discharge home, high-risk patients suitable for immediate hospital admission, and intermediate risk patients suitable for further diagnostic assessment. The protocol will be implemented at the Lund, Helsingborg and Ystad EDs but not at the Malmö and Kristianstad EDs which will be concurrent controls. Patient outcomes will be compared in the 10-month periods before and after the implementation (starting February 1, 2018) both at the protocol-implementing and control hospitals. The primary outcomes are the 30-day rate of acute myocardial infarction/all-cause death and the ED length of stay (LOS) in patients discharged from the ED. Secondary outcomes include the proportion of patients discharged from the ED and of non-ACS-patients admitted to the cardiac care unit, further cardiac testing within 30 days and health care costs.ResultsNo results are available at this time (April 23, 2018). The main results of the study will be presented in 2019. ConclusionIf a 0h/1h protocol implemented in routine care can rapidly identify a large proportion of chest pain patients suitable for early discharge with no need for further cardiac testing, this may reduce ED and hospital crowding, objective testing, health care costs and will benefit both patients and the health care system.
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  • MOKHTARI, ARASH, et al. (författare)
  • Diagnostic Accuracy of High-Sensitivity Cardiac Troponin T at Presentation Combined With History and ECG for Ruling Out Major Adverse Cardiac Events
  • 2016
  • Ingår i: Annals of Emergency Medicine. - : Elsevier BV. - 0196-0644 .- 1097-6760. ; 68:6, s. 649-658
  • Tidskriftsartikel (refereegranskat)abstract
    • Study objective: We evaluate the diagnostic accuracy of a high-sensitivity cardiac troponin T (hs-cTnT) level less than 5 ng/L or less than or equal to 14 ng/L at emergency department (ED) presentation, combined with the emergency physician's assessment of history and ECG, for ruling out major adverse cardiac events within 30 days. Methods: This prospective observational study enrolled consecutive ED chest pain patients. Emergency physicians' assessments of patient history and ECG were collected. The primary outcome was 30-day major adverse cardiac events, defined as acute myocardial infarction, unstable angina, cardiogenic shock, ventricular arrhythmia, atrioventricular block, cardiac arrest, or death of cardiac or unknown cause. Results: A total of 1,138 patients were included in the final analysis. The combination of hs-cTnT less than 5 ng/L, a nonischemic ECG result, and a nonhigh risk history was present for 29.2% of all patients and had a sensitivity of 99.2% (95% confidence interval [CI] 95.6% to 100%), negative predictive value (NPV) of 99.7% (95% CI 98.3% to 100%), and a negative likelihood ratio of 0.02 (95% CI 0 to 0.17) for 30-day major adverse cardiac events. The same combination with hs-cTnT less than or equal to 14 ng/L was present in 66.7% of the patients and had a sensitivity of 92% (95% CI 85.8% to 96.1%), NPV of 98.7% (95% CI 97.6% to 99.4%), and negative likelihood ratio of 0.11 (95% CI 0.06 to 0.20). Conclusion: A single hs-cTnT result of less than 5 ng/L at ED presentation when combined with a nonischemic ECG result and a nonhigh risk history identified 29% of chest pain patients at a very low risk of 30-day major adverse cardiac events. A similar strategy with hs-cTnT less than or equal to 14 ng/L was associated with a higher miss rate.
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  • Mokhtari, Arash X, et al. (författare)
  • Diagnostic values of chest pain history, ECG, troponin and clinical gestalt in patients with chest pain and potential acute coronary syndrome assessed in the emergency department.
  • 2015
  • Ingår i: SpringerPlus. - : Springer Science and Business Media LLC. - 2193-1801. ; 4
  • Tidskriftsartikel (refereegranskat)abstract
    • In the assessment of chest pain patients with suspected acute coronary syndrome (ACS) in the emergency department (ED), physicians rely on global diagnostic impressions ('gestalt'). The aim of this study was to determine the diagnostic value of the ED physician's overall assessment of ACS likelihood, and the values of the main diagnostic modalities underlying this assessment, namely the chest pain history, the ECG and the initial troponin result. 1,151 consecutive ED chest pain patients were prospectively included. The ED physician's interpretation of the chest pain history, the ECG, and the global likelihood of ACS were recorded on special forms. The discharge diagnoses were retrieved from the medical records. A chart review was carried out to determine whether patients with a non-ACS diagnosis at the index visit had ACS or suffered cardiac death within 30 days. The gestalt was better than its components both at ruling in ("Obvious ACS", LR 29) and at ruling out ("No Suspicion of ACS", LR 0.01) ACS. In the "Strong suspicion of ACS" group, 60% of the patients did not have ACS. A positive TnT (LR 24.9) and an ischemic ECG (LR 8.3) were strong predictors of ACS and seemed superior to pain history for ruling in ACS. In patients with a normal TnT and non-ischemic ECG, chest pain history typical of AMI was not a significant predictor of AMI (LR 1.9) while pain history typical of unstable angina (UA) was a moderate predictor of UA (LR 4.7). Clinical gestalt was better than its components both at ruling in and at ruling out ACS, but overestimated the likelihood of ACS when cases were assessed as strong suspicion of ACS. Among the components of the gestalt, TnT and ECG were superior to the chest pain history for ruling in ACS, while pain history was superior for ruling out ACS.
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  • Neumann, J. T., et al. (författare)
  • Application of High-Sensitivity Troponin in Suspected Myocardial Infarction
  • 2019
  • Ingår i: New England Journal of Medicine. - : MASSACHUSETTS MEDICAL SOC. - 0028-4793 .- 1533-4406. ; 380:26, s. 2529-2540
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundData regarding high-sensitivity troponin concentrations in patients presenting to the emergency department with symptoms suggestive of myocardial infarction may be useful in determining the probability of myocardial infarction and subsequent 30-day outcomes. MethodsIn 15 international cohorts of patients presenting to the emergency department with symptoms suggestive of myocardial infarction, we determined the concentrations of high-sensitivity troponin I or high-sensitivity troponin T at presentation and after early or late serial sampling. The diagnostic and prognostic performance of multiple high-sensitivity troponin cutoff combinations was assessed with the use of a derivation-validation design. A risk-assessment tool that was based on these data was developed to estimate the risk of index myocardial infarction and of subsequent myocardial infarction or death at 30 days. ResultsAmong 22,651 patients (9604 in the derivation data set and 13,047 in the validation data set), the prevalence of myocardial infarction was 15.3%. Lower high-sensitivity troponin concentrations at presentation and smaller absolute changes during serial sampling were associated with a lower likelihood of myocardial infarction and a lower short-term risk of cardiovascular events. For example, high-sensitivity troponin I concentrations of less than 6 ng per liter and an absolute change of less than 4 ng per liter after 45 to 120 minutes (early serial sampling) resulted in a negative predictive value of 99.5% for myocardial infarction, with an associated 30-day risk of subsequent myocardial infarction or death of 0.2%; a total of 56.5% of the patients would be classified as being at low risk. These findings were confirmed in an external validation data set. ConclusionsA risk-assessment tool, which we developed to integrate the high-sensitivity troponin I or troponin T concentration at emergency department presentation, its dynamic change during serial sampling, and the time between the obtaining of samples, was used to estimate the probability of myocardial infarction on emergency department presentation and 30-day outcomes.
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  • Pickering, John W., et al. (författare)
  • Rapid Rule-out of Acute Myocardial Infarction With a Single High-Sensitivity Cardiac Troponin T Measurement Below the Limit of Detection A Collaborative Meta-analysis
  • 2017
  • Ingår i: Annals of Internal Medicine. - 0003-4819 .- 1539-3704. ; 166:10, s. 715-724
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: High-sensitivity assays for cardiac troponin T (hs-cTnT) are sometimes used to rapidly rule out acute myocardial infarction (AMI). Purpose: To estimate the ability of a single hs-cTnT concentration below the limit of detection (<0.005 mu g/L) and a nonischemic electrocardiogram (ECG) to rule out AMI in adults presenting to the emergency department (ED) with chest pain. Data Sources: EMBASE and MEDLINE without language restrictions (1 January 2008 to 14 December 2016). Study Selection: Cohort studies involving adults presenting to the ED with possible acute coronary syndrome in whom an ECG and hs-cTnT measurements were obtained and AMI outcomes adjudicated during initial hospitalization. Data Extraction: Investigators of studies provided data on the number of low-risk patients (no new ischemia on ECG and hs-cTnT measurements <0.005 mu g/L) and the number who had AMI during hospitalization (primary outcome) or a major adverse cardiac event (MACE) or death within 30 days (secondary outcomes), by risk classification (low or not low risk). Two independent epidemiologists rated risk of bias of studies. Data Synthesis: Of 9241 patients in 11 cohort studies, 2825 (30.6%) were classified as low risk. Fourteen (0.5%) low-risk patients had AMI. Sensitivity of the risk classification for AMI ranged from 87.5% to 100% in individual studies. Pooled estimated sensitivity was 98.7% (95% CI, 96.6% to 99.5%). Sensitivity for 30-day MACEs ranged from 87.9% to 100%; pooled sensitivity was 98.0% (CI, 94.7% to 99.3%). No low-risk patients died. Limitation: Few studies, variation in timing and methods of reference standard troponin tests, and heterogeneity of risk and prevalence of AMI across studies. Conclusion: A single hs-cTnT concentration below the limit of detection in combination with a nonischemic ECG may successfully rule out AMI in patients presenting to EDs with possible emergency acute coronary syndrome.
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