Aims An accelerated diagnostic algorithm for ruling-in or ruling-out myocardial infarction (MI) after 1 hour (1 h) has recently been derived and internally validated for the Siemens ADVIA Centaur TNIH assay. We aimed to validate the diagnostic performance of the TNIH 0 h/1 h algorithm ad modum Boeddinghaus in a Danish cohort. Methods and results Patients with chest pain suggestive of MI were prospectively enrolled. High-sensitive troponin I (TNIH) was measured at admission (0 h) and after 30 minutes (30 m), 1 h, and 3 hours (3 h). We externally validated the TNIH 0 h/1 h algorithm ad modum Boeddinghaus in Danish patients. Moreover, we applied the algorithm using the second TNIH measurement at 30 m instead of 1 h. We enrolled 1003 patients: median (Q1–Q3) age 64 (52–74) years, 42% female, and 23% with previous MI. Myocardial infarction was the final diagnosis in 9% of patients. Median (Q1–Q3) times from admission to 30 m and 1 h blood draw were 35 min (30–37 min) and 67 min (62–75 min), respectively. Using the 0 h and 1 h results, 468 (47%) patients were assigned to rule-out, 104 (10%) to rule-in, and 431 (43%) to the observational zone. This resulted in a negative predictive value of 100% (95% confidence interval: 99.2–100%), sensitivity of 100% (95.9–100%), positive predictive value of 79.8 (70.8–87.0%), and specificity of 97.7% (96.5–98.6%). The diagnostic performance after 30 m was similar. Conclusions The TNIH 0 h/1 h algorithm ad modum Boeddinghaus performed excellently for rule-out of MI in a Danish cohort. The Boeddinghaus algorithm also performed excellently after only 30 m. Trial registration number NCT03634384. Trial registry name and URL Rapid Use of High-Sensitive Cardiac Troponin I for Ruling-in and Ruling-out Acute Myocardial Infarction (RACING-MI), https://clinicaltrials.gov/ct2/show/NCT03634384.

中文翻译：

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在丹麦队列中快速评估急性心肌梗死的高灵敏度肌钙蛋白 I 算法的外部验证

目的 一种加速诊断算法，用于在 1 小时 (1 h) 后排除或排除心肌梗塞 (MI)，最近推导出并在内部验证了 Siemens ADVIA Centaur TNIH 测定。我们旨在验证丹麦队列中 TNIH 0 h/1 h 算法 ad modum Boeddinghaus 的诊断性能。方法和结果 前瞻性地招募了提示 MI 的胸痛患者。在入院时（0 小时）和 30 分钟（30 分钟）、1 小时和 3 小时（3 小时）后测量高敏肌钙蛋白 I (TNIH)。我们在丹麦患者中外部验证了 TNIH 0 h/1 h 算法 ad modum Boeddinghaus。此外，我们在 30 m 而不是 1 h 处使用第二次 TNIH 测量来应用该算法。我们招募了 1003 名患者：中位（Q1-Q3）年龄 64（52-74）岁，42% 为女性，23% 有既往 MI。9% 的患者最终诊断为心肌梗死。从入院到 30 m 和 1 h 抽血的中位时间（Q1-Q3）分别为 35 分钟（30-37 分钟）和 67 分钟（62-75 分钟）。使用 0 小时和 1 小时结果，468 名 (47%) 患者被分配到排除区，104 名 (10%) 被分配到排除区，431 名 (43%) 被分配到观察区。这导致阴性预测值为 100%（95% 置信区间：99.2-100%），敏感性为 100%（95.9-100%），阳性预测值为 79.8（70.8-87.0%），特异性为 97.7% (96.5–98.6%)。30 m 后的诊断性能相似。结论 TNIH 0 h/1 h 算法 ad modum Boeddinghaus 在丹麦队列中排除 MI 表现出色。Boeddinghaus 算法在仅 30 m 后也表现出色。试用注册号 NCT03634384。