Reichlin Tobias, Twerenbold Raphael, Wildi Karin, Gimenez Maria Rubini, Bergsma Nathalie, Haaf Philip, Druey Sophie, Puelacher Christian, Moehring Berit, Freese Michael, Stelzig Claudia, Krivoshei Lian, Hillinger Petra, Jäger Cedric, Herrmann Thomas, Kreutzinger Philip, Radosavac Milos, Weidmann Zoraida Moreno, Pershyna Kateryna, Honegger Ursina, Wagener Max, Vuillomenet Thierry, Campodarve Isabel, Bingisser Roland, Miró Òscar, Rentsch Katharina, Bassetti Stefano, Osswald Stefan, Mueller Christian
Department of Cardiology and Cardiovascular Research Institute Basel (Reichlin, Twerenbold, Wildi, Rubini Gimenez, Bergsma, Haaf, Druey, Puelacher, Moehring, Freese, Stelzig, Krivoshei, Hillinger, Jäger, Herrmann, Kreutzinger, Radosavac, Weidmann, Pershyna, Honegger, Wagener, Vuillomenet, Osswald, Mueller), Universitätsspital Basel, Basel, Switzerland; Emergency Department (Rubini Gimenez, Campodarve), Internal Medicine Department, Hospital del Mar - Institut Municipal d'Investigació Mèdica, Barcelona, Spain; Emergency Department (Bingisser), Universitätsspital Basel, Basel, Switzerland; Emergency Department (Miró), Hospital Clínic de Barcelona, Barcelona, Spain; Laboratory Medicine (Rentsch), Universitätsspital Basel, Basel, Switzerland; Kantonsspital Olten (Bassetti), Olten, Switzerland.
Department of Cardiology and Cardiovascular Research Institute Basel (Reichlin, Twerenbold, Wildi, Rubini Gimenez, Bergsma, Haaf, Druey, Puelacher, Moehring, Freese, Stelzig, Krivoshei, Hillinger, Jäger, Herrmann, Kreutzinger, Radosavac, Weidmann, Pershyna, Honegger, Wagener, Vuillomenet, Osswald, Mueller), Universitätsspital Basel, Basel, Switzerland; Emergency Department (Rubini Gimenez, Campodarve), Internal Medicine Department, Hospital del Mar - Institut Municipal d'Investigació Mèdica, Barcelona, Spain; Emergency Department (Bingisser), Universitätsspital Basel, Basel, Switzerland; Emergency Department (Miró), Hospital Clínic de Barcelona, Barcelona, Spain; Laboratory Medicine (Rentsch), Universitätsspital Basel, Basel, Switzerland; Kantonsspital Olten (Bassetti), Olten, Switzerland
CMAJ. 2015 May 19;187(8):E243-E252. doi: 10.1503/cmaj.141349. Epub 2015 Apr 13.
We 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).
In 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.
Acute 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).
This 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.
ClinicalTrials.gov, NCT00470587.
我们旨在前瞻性验证一种使用高敏心肌肌钙蛋白T测量的新型1小时算法，用于急性心肌梗死（MI）的早期排除和诊断。
在一项多中心研究中，我们纳入了1320名因疑似急性MI就诊于急诊科的患者。将包含基线值以及第1小时内绝对变化的高敏心肌肌钙蛋白T 1小时算法与最终诊断进行验证。最终诊断由2名独立心脏病专家根据所有可用信息进行判定，包括冠状动脉造影、超声心动图、随访数据以及高敏心肌肌钙蛋白T水平的系列测量。
17.3%的患者最终诊断为急性MI。应用高敏心肌肌钙蛋白T 1小时算法，786例（59.5%）患者被分类为“排除”，216例（16.4%）被分类为“诊断”，318例（24.1%）被分类到“观察区”。排除区对急性MI的敏感性和阴性预测值分别为99.6%（95%置信区间[CI] 97.6% - 99.9%）和99.9%（95% CI 99.3% - 100%）。诊断区对急性MI的特异性和阳性预测值分别为95.7%（95% CI 94.3% - 96.8%）和78.2%（95% CI 72.1% - 83.6%）。该1小时算法提供的阴性和阳性预测值高于使用单一临界值的高敏心肌肌钙蛋白T标准解读（均p < 0.05）。排除、观察和诊断组患者的30天累积死亡率分别为0.0%、1.6%和1.9%（p = 0.001）。
这种纳入高敏心肌肌钙蛋白T基线值和第1小时内绝对变化的快速策略，通过对四分之三的患者进行安全排除以及准确诊断，显著加速了疑似急性MI患者的管理。
ClinicalTrials.gov，NCT00470587。
