Background Chest pain is a major cause of medical evaluation at emergency department (ED) and demands observation to exclude the diagnosis of acute myocardial infarction (AMI). High-sensitivity cardiac troponin assays used as isolated measure and by 0 h and 1 h algorithms are accepted as a rule-in/rule-out strategy but there is a lack of validation in specific populations. Methods The IN-HOspital Program to systematizE chest pain protocol (In Hope study) is a multicentre study that prospectively included patients admitted to the ED due to suspected symptoms of AMI at 16 sites in Brazil. Medical decisions of all patients followed the standard approach of 0/3-h protocol but, in addition, blood samples were also collected at 0 and 1 hour and sent to a central laboratory (core lab) to measure high-sensitivity troponin T (hs-cTnT). To assess the theoretical performance of 0/1-h algorithm, troponin < 12 ng/L with a delta <­­­ 3 was considered rule out while a value ≥ 52 and/or a delta ≥ 5 was considered a rule in criteria (the remaining were considered as observation group). The main objective of the study was to assess, in a population managed by the 0/3-h protocol, the accuracy of 0/1-h algorithm overall and in groups with higher probability of AMI. All patients were followed for 30 days, and potential events were adjudicated. In addition to the prospective cohort, a retrospective analysis was performed assessing all patients with hs-cTnT measured during the year of 2021 but not included in the prospective cohort, regardless the indication of the test. Results A total of 5.497 patients were included (583 in the prospective and 4.914 in the retrospective analysis). The prospective cohort had a mean age of 57.3 (± 14.8) and 45.6% of females with a mean HEART score of 4.0 ± 2.2. By the core lab analysis, 74.4% would be eligible for a rule-out approach (45.3% of HEART score > 3) while 7.3% would fit the rule-in criteria. In this rule-out group, the negative predictive value for index AMI was 100% (99.1-100) overall and regardless clinical scores. At 30 days, no death or AMI occurred in the rule-out group of both 0/1 and 0/3-hour while 52.4% of the patients in the rule-in group (0/1-hour) were considered as AMI by adjudication. In the observation group (grey zone) of 0/1- hour algorithm, GRACE discriminated the risk of these patients better than HEART score. In the retrospective analysis, 1.091 patients had a troponin value < 5 ng/L and there were no cardiovascular deaths at 30 days in this group. Among all 4.914 patients, the 30-day risk of AMI or cardiovascular death increased according to the level of troponin: 0% in the group < 5 ng/L, 0.6% between 5 and 14 ng/L, 2.2% between 14 and 42 ng/L, 6.3% between 42 and 90 ng/L and 7.7% in the level ≥ 90 ng/L. Conclusions In this large multicentre study, a 0/1-h algorithm had the potential to classify as rule in or out almost 80% of the patients. The rule-out protocol had high negative predictive value regardless of clinical risk scores. Categories of levels of hs-cTn T also showed good accuracy in discriminating risk of the patients with a very favourable prognosis for cardiovascular death in the group with values < 5 ng/L.

中文翻译：

---

0/1 小时算法和高敏肌钙蛋白 T 单一截止测量在不同人群中的潜在性能：IN-HOPE 研究的主要结果

背景 胸痛是急诊科 (ED) 进行医学评估的主要原因，需要观察以排除急性心肌梗死 (AMI) 的诊断。用作单独测量的高灵敏度心肌肌钙蛋白测定以及 0 小时和 1 小时算法被接受为一种排除策略，但在特定人群中缺乏验证。方法 胸痛方案系统化住院计划（In Hope 研究）是一项多中心研究，前瞻性地纳入了巴西 16 个地点因疑似 AMI 症状而入住急诊室的患者。所有患者的医疗决策均遵循 0/3 小时方案的标准方法，但此外，还在 0 小时和 1 小时采集血样并送往中心实验室（核心实验室）测量高敏肌钙蛋白 T (hs -cTnT）。为了评估0/1-h算法的理论性能，肌钙蛋白<0/1-h算法的理论性能。12 ng/L，δ<1 3 被视为排除，而值 ≥ 52 和/或 delta ≥ 5 被视为标准中的规则（其余被视为观察组）。该研究的主要目的是在 0/3-h 方案管理的人群中评估 0/1-h 算法的整体准确性以及 AMI 概率较高的群体。所有患者均接受 30 天的随访，并判定潜在事件。除了前瞻性队列之外，还进行了回顾性分析，评估了 2021 年测量的所有 hs-cTnT 患者，但不包括在前瞻性队列中，无论测试的适应症如何。结果共纳入5.497例患者（前瞻性分析583例，回顾性分析4.914例）。前瞻性队列的平均年龄为 57.3 岁 (± 14.8)，其中 45.6% 的女性平均 HEART 评分为 4.0 ± 2.2。根据核心实验室分析，74.4% 的人符合排除方法（45.3% 的 HEART 评分> 3），而 7.3% 的人符合排除标准。在该排除组中，无论临床评分如何，AMI 指数的总体阴性预测值为 100% (99.1-100)。30天时，排除组0/1小时和0/3小时均未发生死亡或AMI，而排除组（0/1小时）有52.4%的患者被认为是AMI裁决。在0/1小时算法的观察组（灰色区域）中，GRACE比HEART评分更好地区分这些患者的风险。在回顾性分析中，1.091名患者的肌钙蛋白值<0。5 ng/L，该组在 30 天时没有心血管死亡。在所有 4.914 名患者中，AMI 或心血管死亡的 30 天风险根据肌钙蛋白水平而增加：组中 0% < 5 ng/L，5 至 14 ng/L 之间为 0.6%，14 至 42 ng/L 之间为 2.2%，42 至 90 ng/L 之间为 6.3%，≥ 90 ng/L 水平为 7.7%。结论 在这项大型多中心研究中，0/1-h 算法有可能将近 80% 的患者分类为排除或排除。无论临床风险评分如何，排除方案均具有较高的阴性预测价值。hs-cTn T水平的类别在区分具有非常有利的心血管死亡预后的患者的风险方面也表现出良好的准确性，该组中的值<1。5纳克/升。