急性冠脉综合征评估 (APACE) 研究的有利预测因素 (APACE)
2025年12月5日 更新者：University Hospital, Basel, Switzerland
在急诊室对疑似急性冠状动脉综合征患者进行分类是一项耗时的诊断挑战。 因此，需要高灵敏度的心肌损伤早期标志物，以便更快地排除急性心肌梗塞 (AMI)，尤其是 AMI 胸痛发作后的前 3 至 4 小时（“肌钙蛋白盲期”）。
因此，我们检验了这样的假设：使用细致的患者病史和新型心脏标志物可以更快地检测或排除因急性胸痛而到急诊科就诊的患者的 AMI。
这项前瞻性队列研究旨在招募过去 12 小时内因休息时出现急性胸痛而前往急诊科就诊的患者。 将抽取一些血液样本来检测新标记物，并将其与诊断 AMI（高敏心肌肌钙蛋白 T）的金标准进行比较。 所有患者将在3、12、24和60个月时通过电话联系以确定功能状态、主要不良心脏事件（死亡、心肌梗死、冠状动脉搭桥术、经皮冠状动脉介入治疗）以及心脏检查结果（压力测试） ，冠状动脉造影）（如果进行的话）。
研究概览
详细说明
背景：在急诊室对疑似急性冠状动脉综合征患者进行分类是一项耗时的诊断挑战。 对冠状动脉疾病可能性较低的患者进行分诊和管理往往会导致过高的住院费用。 因此，需要高灵敏度的心肌损伤早期标志物，以更快地排除急性心肌梗塞（AMI）。
心肌肌钙蛋白（T 和 I）由于其检测心肌细胞损伤的高敏感性和特异性，目前是明确 AMI 诊断的金标准。 不幸的是，在 AMI 胸痛发作后 3 至 4 小时内（“肌钙蛋白盲期”），目前的外周血检测无法检测到肌钙蛋白。
与肌钙蛋白相比，新型高灵敏肌钙蛋白 I/T、缺血修饰白蛋白和胎盘生长因子等新型心脏标志物已显示出一定的优势，例如 AMI 阴性预测值高、外周血可早期验证以及作为独立风险标志物的可能价值。 然而，仍然缺乏对大量未经选择的急诊科患者的临床评估。
目的：检验以下假设：使用详细的患者病史和新型心脏标志物（包括高敏肌钙蛋白 I/T、髓过氧化物酶、缺血修饰白蛋白、胎盘生长因子）可以更快地检测或排除急性心肌梗死患者。胸痛去急诊室。
患者和方法：前瞻性队列研究旨在招募在过去 12 小时内因静息时出现急性胸痛而前往急诊科就诊的未经选择的患者。 将抽取几份用于检测新标志物的血样（基线、1、2、3 和 6 小时），并与诊断 AMI（高敏心肌肌钙蛋白 T）的金标准进行比较。 患者的时间安排和治疗由主治医生决定，并将根据医院的标准住院常规进行。 所有患者将在6、12、24和60个月时通过电话联系以确定功能状态、主要不良心脏事件（死亡、心肌梗塞、冠状动脉搭桥术、经皮冠状动脉介入治疗）以及心脏检查结果（压力测试） ，冠状动脉造影）（如果进行的话）。
预期结果：我们的假设是，使用详细的患者病史和新型心脏标志物可以通过在“肌钙蛋白盲”期内提供高阴性预测值的 AMI 早期诊断来改善 AMI 的检测。
意义：早期检测外周血中的心肌坏死有助于更快地排除AMI。 此外，它还可以对 AMI 进行更快速的诊断和适当的治疗。 这可以显着改善患者管理并降低住院费用。
研究类型
观察性的
注册 (实际的)
10000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Genova、意大利
- Emergency Department San Martino Hospital
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Brno、捷克语
- Masaryk University Brno
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Zabrze、波兰
- Medical University of Silesia
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Basel、瑞士、4031
- University Hospital of Basel
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Bottmingen、瑞士
- Kantonsspital Baselland, Standort Bruderholz
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Liestal、瑞士
- Kantonsspital Baselland, Standort Liestal
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Lucerne、瑞士
- Klinik St. Anna
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Olten、瑞士
- Kantonsspital Olten
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Schlieren、瑞士
- Spital Limmattal
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Zurich、瑞士
- Universitätsspital Zürich
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Barcelona、西班牙、08036
- Hospital Clinic of Barcelona
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Barcelona、西班牙
- Hospital Del Mar
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Madrid、西班牙
- Hospital Clinico San Carlos
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
取样方法
非概率样本
研究人群
因典型心绞痛或在休息或轻微活动时出现其他胸部感觉（疑似由心肌缺血引起）而到急诊科就诊的患者。
就诊前最后 12 小时内出现症状。
描述
纳入标准：
- 到急诊室就诊的患者
- 典型的心绞痛或怀疑由心肌缺血引起的其他胸部感觉
- 休息或轻微劳累时出现症状
- 就诊前 12 小时内出现症状
- 书面知情同意书
排除标准：
- 年龄 < 18 岁
- 心源性休克
- 需要定期透析的终末期肾病
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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各种生物标志物、详细病史和检查以及心电图检查结果对急性心肌梗死早期诊断的诊断效用
大体时间：入院时
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入院时
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christian Mueller, MD、University Hospital of Basel
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Klinkenberg LJ, Wildi K, van der Linden N, Kouw IW, Niens M, Twerenbold R, Rubini Gimenez M, Puelacher C, Daniel Neuhaus J, Hillinger P, Nestelberger T, Boeddinghaus J, Grimm K, Sabti Z, Bons JA, van Suijlen JD, Tan FE, Ten Kate J, Bekers O, van Loon LJ, van Dieijen-Visser MP, Mueller C, Meex SJ. Diurnal Rhythm of Cardiac Troponin: Consequences for the Diagnosis of Acute Myocardial Infarction. Clin Chem. 2016 Dec;62(12):1602-1611. doi: 10.1373/clinchem.2016.257485. Epub 2016 Oct 5.
- Boeddinghaus J, Nestelberger T, Twerenbold R, Neumann JT, Lindahl B, Giannitsis E, Sorensen NA, Badertscher P, Jann JE, Wussler D, Puelacher C, Rubini Gimenez M, Wildi K, Strebel I, Du Fay de Lavallaz J, Selman F, Sabti Z, Kozhuharov N, Potlukova E, Rentsch K, Miro O, Martin-Sanchez FJ, Morawiec B, Parenica J, Lohrmann J, Kloos W, Buser A, Geigy N, Keller DI, Osswald S, Reichlin T, Westermann D, Blankenberg S, Mueller C; APACE, BACC, and TRAPID-AMI Investigators. Impact of age on the performance of the ESC 0/1h-algorithms for early diagnosis of myocardial infarction. Eur Heart J. 2018 Nov 7;39(42):3780-3794. doi: 10.1093/eurheartj/ehy514.
- Koechlin L, Boeddinghaus J, Lopez-Ayala P, Nestelberger T, Wussler D, Mais F, Twerenbold R, Zimmermann T, Wildi K, Koppen AM, Miro O, Martin-Sanchez FJ, Kawecki D, Geigy N, Keller DI, Christ M, Buser A, Gimenez MR, Bernasconi L, Hammerer-Lercher A, Mueller C; APACE investigators. Diagnostic discrimination of a novel high-sensitivity cardiac troponin I assay and derivation/validation of an assay-specific 0/1h-algorithm. Am Heart J. 2023 Jan;255:58-70. doi: 10.1016/j.ahj.2022.10.007. Epub 2022 Oct 13.
- Koechlin L, Boeddinghaus J, Nestelberger T, Lopez-Ayala P, Shrestha S, Wussler D, Haeni N, Walter JE, Twerenbold R, Eckstein FS, Reuthebuch O, McCord J, Nowak RM, Christenson RH, deFilippi CR, Apple FS, Mueller C; APACE and High-US investigators. Lower diagnostic accuracy of hs-cTnI in patients with prior coronary artery bypass grafting. Int J Cardiol. 2022 May 1;354:1-6. doi: 10.1016/j.ijcard.2022.02.025. Epub 2022 Feb 18.
- Kaier TE, Twerenbold R, Lopez-Ayala P, Nestelberger T, Boeddinghaus J, Alaour B, Huber IM, Zhi Y, Koechlin L, Wussler D, Wildi K, Shrestha S, Strebel I, Miro O, Martin-Sanchez JF, Christ M, Kawecki D, Keller DI, Rubini Gimenez M, Marber M, Mueller C; APACE Investigators. A 0/1h-algorithm using cardiac myosin-binding protein C for early diagnosis of myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2022 Jun 7;11(4):325-335. doi: 10.1093/ehjacc/zuac007.
- Prepoudis A, Koechlin L, Nestelberger T, Boeddinghaus J, Lopez-Ayala P, Wussler D, Zimmermann T, Rubini Gimenez M, Strebel I, Puelacher C, Shrestha S, Keller DI, Christ M, Gualandro DM, Twerenbold R, Martinez-Nadal G, Lopez-Barbeito B, Miro O, Mueller C; APACE investigators. Incidence, clinical presentation, management, and outcome of acute pericarditis and myopericarditis. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):137-147. doi: 10.1093/ehjacc/zuab108.
- Koechlin L, Boeddinghaus J, Nestelberger T, Lopez-Ayala P, Wussler D, Shrestha S, Resa T, Wildi K, Bakula A, Frey S, Miro O, Martin-Sanchez FJ, Strebel I, Gualandro DM, Eckstein FS, Reuthebuch O, Keller DI, Twerenbold R, Gimenez MR, Mueller C; APACE investigators. Performance of the ESC 0/2h-algorithm using high-sensitivity cardiac troponin I in the early diagnosis of myocardial infarction. Am Heart J. 2021 Dec;242:132-137. doi: 10.1016/j.ahj.2021.08.008. Epub 2021 Sep 9.
- Boeddinghaus J, Lopez-Ayala P, Nestelberger T, Koechlin L, Munch T, Miro O, Gimenez MR, Mueller C; APACE Investigators. Prospective Validation of the ESC 0/1h-Algorithm Using High-Sensitivity Cardiac Troponin I. Am J Cardiol. 2021 Nov 1;158:152-153. doi: 10.1016/j.amjcard.2021.08.007. Epub 2021 Aug 30. No abstract available.
- Nestelberger T, Boeddinghaus J, Gimenez MR, Lopez-Ayala P, Ratmann PD, Badertscher P, Wildi K, Wussler D, Koechlin L, Arslani K, Zimmermann T, Freese M, Rinderknecht T, Miro O, Martin-Sanchez FJ, Kawecki D, Geigy N, Keller D, Twerenbold R, Muller C; APACE investigators. Direct comparison of high-sensitivity cardiac troponin T and I in the early differentiation of type 1 vs. type 2 myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2022 Jan 12;11(1):62-74. doi: 10.1093/ehjacc/zuab039.
- Boeddinghaus J, Nestelberger T, Lopez-Ayala P, Koechlin L, Buechi M, Miro O, Keller DI, Gimenez MR, Twerenbold R, Mueller C; APACE Investigators. Diagnostic Performance of the European Society of Cardiology 0/1-h Algorithms in Late Presenters. J Am Coll Cardiol. 2021 Mar 9;77(9):1264-1267. doi: 10.1016/j.jacc.2021.01.004. No abstract available.
- Koechlin L, Boeddinghaus J, Nestelberger T, Miro O, Fuenzalida C, Martinez-Nadal G, Lopez B, Wussler D, Walter J, Zimmermann T, Troester V, Lopez-Ayala P, Baumgartner B, Ratmann PD, Diebold M, Prepoudis A, Huber J, Christ M, Wildi K, Rubini Gimenez M, Strebel I, Gualandro DM, Martin-Sanchez FJ, Kawecki D, Keller DI, Reuthebuch O, Eckstein FS, Reichlin T, Twerenbold R, Mueller C; APACE investigators. Clinical presentation of patients with prior coronary artery bypass grafting and suspected acute myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Oct 1;10(7):746-755. doi: 10.1093/ehjacc/zuaa020.
- Troester V, Strebel I, Nestelberger T, Boeddinghaus J, Rubini Gimenez M, Lopez-Ayala P, Koechlin L, Glarner N, Prepoudis A, Miro O, Martin-Sanchez FJ, Kawecki D, Keller DI, Twerenbold R, Mueller C; APACE Investigators *. Association of Previous Myocardial Infarction and Time to Presentation With Suspected Acute Myocardial Infarction. J Am Heart Assoc. 2021 Jan 5;10(1):e017829. doi: 10.1161/JAHA.120.017829. Epub 2020 Dec 26. No abstract available.
- Rubini Gimenez M, Wildi K, Wussler D, Koechlin L, Boeddinghaus J, Nestelberger T, Badertscher P, Sedlmayer R, Puelacher C, Zimmermann T, du Fay de Lavallaz J, Lopez-Ayala P, Leu K, Rentsch K, Miro O, Lopez B, Martin-Sanchez FJ, Bustamante J, Kawecki D, Parenica J, Lohrmann J, Kloos W, Buser A, Keller DI, Reichlin T, Twerenbold R, Mueller C. Early kinetics of cardiac troponin in suspected acute myocardial infarction. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):502-509. doi: 10.1016/j.rec.2020.04.008. Epub 2020 May 22. English, Spanish.
- Nestelberger T, Boeddinghaus J, Greenslade J, Parsonage WA, Than M, Wussler D, Lopez-Ayala P, Zimmermann T, Meier M, Troester V, Badertscher P, Koechlin L, Wildi K, Anwar M, Freese M, Keller DI, Reichlin T, Twerenbold R, Cullen L, Mueller C; APACE and ADAPT Investigators. Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay. Clin Chem. 2019 Nov;65(11):1437-1447. doi: 10.1373/clinchem.2019.305193. Epub 2019 Sep 30.
- Boeddinghaus J, Twerenbold R, Nestelberger T, Koechlin L, Wussler D, Meier M, Troester V, Zimmermann T, Badertscher P, Wildi K, Rubini Gimenez M, Lopez-Ayala P, Potlukova E, Miro O, Martin-Sanchez FJ, Kawecki D, Geigy N, Keller DI, Reichlin T, Mueller C; APACE investigators. Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction. Clin Chem. 2019 Nov;65(11):1426-1436. doi: 10.1373/clinchem.2019.304725. Epub 2019 Sep 30.
- Nestelberger T, Boeddinghaus J, Wussler D, Twerenbold R, Badertscher P, Wildi K, Miro O, Lopez B, Martin-Sanchez FJ, Muzyk P, Koechlin L, Baumgartner B, Meier M, Troester V, Rubini Gimenez M, Puelacher C, du Fay de Lavallaz J, Walter J, Kozhuharov N, Zimmermann T, Gualandro DM, Michou E, Potlukova E, Geigy N, Keller DI, Reichlin T, Mueller C; APACE Investigators. Predicting Major Adverse Events in Patients With Acute Myocardial Infarction. J Am Coll Cardiol. 2019 Aug 20;74(7):842-854. doi: 10.1016/j.jacc.2019.06.025.
- Nestelberger T, Cullen L, Lindahl B, Reichlin T, Greenslade JH, Giannitsis E, Christ M, Morawiec B, Miro O, Martin-Sanchez FJ, Wussler DN, Koechlin L, Twerenbold R, Parsonage W, Boeddinghaus J, Rubini Gimenez M, Puelacher C, Wildi K, Buerge T, Badertscher P, DuFaydeLavallaz J, Strebel I, Croton L, Bendig G, Osswald S, Pickering JW, Than M, Mueller C; APACE, ADAPT and TRAPID-AMI Investigators. Diagnosis of acute myocardial infarction in the presence of left bundle branch block. Heart. 2019 Oct;105(20):1559-1567. doi: 10.1136/heartjnl-2018-314673. Epub 2019 May 29.
- Hillinger P, Strebel I, Abacherli R, Twerenbold R, Wildi K, Bernhard D, Nestelberger T, Boeddinghaus J, Badertscher P, Wussler D, Koechlin L, Zimmermann T, Puelacher C, Rubini Gimenez M, du Fay de Lavallaz J, Walter J, Geigy N, Keller DI, Reichlin T, Mueller C; APACE Investigators. Prospective validation of current quantitative electrocardiographic criteria for ST-elevation myocardial infarction. Int J Cardiol. 2019 Oct 1;292:1-12. doi: 10.1016/j.ijcard.2019.04.041. Epub 2019 Apr 11.
- Boeddinghaus J, Nestelberger T, Twerenbold R, Koechlin L, Meier M, Troester V, Wussler D, Badertscher P, Wildi K, Puelacher C, du Fay de Lavallaz J, Rubini Gimenez M, Zimmermann T, Hafner B, Potlukova E, Miro O, Martin-Sanchez FJ, Keller DI, Reichlin T, Mueller C; APACE investigators. High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction. Clin Chem. 2019 Jul;65(7):893-904. doi: 10.1373/clinchem.2018.300061. Epub 2019 Apr 15.
- Morawiec B, Boeddinghaus J, Wussler D, Badertscher P, Koechlin L, Metry F, Twerenbold R, Nestelberger T, Kawecki D, Mueller C; APACE Investigators. Modified HEART Score and High-Sensitivity Cardiac Troponin in Patients With Suspected Acute Myocardial Infarction. J Am Coll Cardiol. 2019 Feb 26;73(7):873-875. doi: 10.1016/j.jacc.2018.12.013. No abstract available.
- Wildi K, Nestelberger T, Wussler D, Boeddinghaus J, Badertscher P, Koechlin L, Duwe P, Rubini Gimenez M, Twerenbold R, Mueller C. Impact of Food and Drug Administration Regulatory Approach on the 0/2-Hour Algorithm for Rapid Triage of Suspected Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 Jan;12(1):e005188. doi: 10.1161/CIRCOUTCOMES.118.005188. No abstract available.
- Boeddinghaus J, Nestelberger T, Badertscher P, Twerenbold R, Fitze B, Wussler D, Strebel I, Rubini Gimenez M, Wildi K, Puelacher C, du Fay de Lavallaz J, Oehen L, Walter J, Miro O, Martin-Sanchez FJ, Morawiec B, Potlukova E, Keller DI, Reichlin T, Mueller C; APACE Investigators. Predicting Acute Myocardial Infarction with a Single Blood Draw. Clin Chem. 2019 Mar;65(3):437-450. doi: 10.1373/clinchem.2018.294124. Epub 2019 Jan 9.
- Wildi K, Boeddinghaus J, Nestelberger T, Twerenbold R, Badertscher P, Wussler D, Gimenez MR, Puelacher C, du Fay de Lavallaz J, Dietsche S, Walter J, Kozhuharov N, Morawiec B, Miro O, Javier Martin-Sanchez F, Subramaniam S, Geigy N, Keller DI, Reichlin T, Mueller C; APACE investigators. Comparison of fourteen rule-out strategies for acute myocardial infarction. Int J Cardiol. 2019 May 15;283:41-47. doi: 10.1016/j.ijcard.2018.11.140. Epub 2018 Dec 3.
- Boeddinghaus J, Twerenbold R, Nestelberger T, Badertscher P, Wildi K, Puelacher C, du Fay de Lavallaz J, Keser E, Rubini Gimenez M, Wussler D, Kozhuharov N, Rentsch K, Miro O, Martin-Sanchez FJ, Morawiec B, Stefanelli S, Geigy N, Keller DI, Reichlin T, Mueller C; APACE Investigators. Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction. Clin Chem. 2018 Sep;64(9):1347-1360. doi: 10.1373/clinchem.2018.286906. Epub 2018 Jun 25.
- Wildi K, Singeisen H, Twerenbold R, Badertscher P, Wussler D, Klinkenberg LJJ, Meex SJR, Nestelberger T, Boeddinghaus J, Miro O, Martin-Sanchez FJ, Morawiec B, Muzyk P, Parenica J, Keller DI, Geigy N, Potlukova E, Sabti Z, Kozhuharov N, Puelacher C, du Fay de Lavallaz J, Rubini Gimenez M, Shrestha S, Marzano G, Rentsch K, Osswald S, Reichlin T, Mueller C; APACE Investigators. Circadian rhythm of cardiac troponin I and its clinical impact on the diagnostic accuracy for acute myocardial infarction. Int J Cardiol. 2018 Nov 1;270:14-20. doi: 10.1016/j.ijcard.2018.05.136. Epub 2018 Jun 4.
- van der Linden N, Wildi K, Twerenbold R, Pickering JW, Than M, Cullen L, Greenslade J, Parsonage W, Nestelberger T, Boeddinghaus J, Badertscher P, Rubini Gimenez M, Klinkenberg LJJ, Bekers O, Schoni A, Keller DI, Sabti Z, Puelacher C, Cupa J, Schumacher L, Kozhuharov N, Grimm K, Shrestha S, Flores D, Freese M, Stelzig C, Strebel I, Miro O, Rentsch K, Morawiec B, Kawecki D, Kloos W, Lohrmann J, Richards AM, Troughton R, Pemberton C, Osswald S, van Dieijen-Visser MP, Mingels AM, Reichlin T, Meex SJR, Mueller C. Combining High-Sensitivity Cardiac Troponin I and Cardiac Troponin T in the Early Diagnosis of Acute Myocardial Infarction. Circulation. 2018 Sep 4;138(10):989-999. doi: 10.1161/CIRCULATIONAHA.117.032003.
- Rubini Gimenez M, Badertscher P, Twerenbold R, Boeddinghaus J, Nestelberger T, Wussler D, Miro O, Martin-Sanchez FJ, Reichlin T, Mueller C. Impact of the US Food and Drug Administration-Approved Sex-Specific Cutoff Values for High-Sensitivity Cardiac Troponin T to Diagnose Myocardial Infarction. Circulation. 2018 Apr 24;137(17):1867-1869. doi: 10.1161/CIRCULATIONAHA.117.031940. No abstract available.
- Badertscher P, Boeddinghaus J, Nestelberger T, Twerenbold R, Wildi K, Sabti Z, Puelacher C, Rubini Gimenez M, Pfaffli J, Flores D, du Fay de Lavallaz J, Miro O, Martin-Sanchez FJ, Morawiec B, Lohrmann J, Buser A, Keller DI, Geigy N, Reichlin T, Mueller C. Effect of Acute Coronary Syndrome Probability on Diagnostic and Prognostic Performance of High-Sensitivity Cardiac Troponin. Clin Chem. 2018 Mar;64(3):515-525. doi: 10.1373/clinchem.2017.279513. Epub 2018 Jan 17.
- Twerenbold R, Badertscher P, Boeddinghaus J, Nestelberger T, Wildi K, Puelacher C, Sabti Z, Rubini Gimenez M, Tschirky S, du Fay de Lavallaz J, Kozhuharov N, Sazgary L, Mueller D, Breidthardt T, Strebel I, Flores Widmer D, Shrestha S, Miro O, Martin-Sanchez FJ, Morawiec B, Parenica J, Geigy N, Keller DI, Rentsch K, von Eckardstein A, Osswald S, Reichlin T, Mueller C. 0/1-Hour Triage Algorithm for Myocardial Infarction in Patients With Renal Dysfunction. Circulation. 2018 Jan 30;137(5):436-451. doi: 10.1161/CIRCULATIONAHA.117.028901. Epub 2017 Nov 3.
- Nestelberger T, Boeddinghaus J, Badertscher P, Twerenbold R, Wildi K, Breitenbucher D, Sabti Z, Puelacher C, Rubini Gimenez M, Kozhuharov N, Strebel I, Sazgary L, Schneider D, Jann J, du Fay de Lavallaz J, Miro O, Martin-Sanchez FJ, Morawiec B, Kawecki D, Muzyk P, Keller DI, Geigy N, Osswald S, Reichlin T, Mueller C; APACE Investigators. Effect of Definition on Incidence and Prognosis of Type 2 Myocardial Infarction. J Am Coll Cardiol. 2017 Sep 26;70(13):1558-1568. doi: 10.1016/j.jacc.2017.07.774.
- Twerenbold R, Badertscher P, Boeddinghaus J, Nestelberger T, Wildi K, Rubini Gimenez M, Miro O, Martin-Sanchez FJ, Reichlin T, Mueller C. Effect of the FDA Regulatory Approach on the 0/1-h Algorithm for Rapid Diagnosis of MI. J Am Coll Cardiol. 2017 Sep 19;70(12):1532-1534. doi: 10.1016/j.jacc.2017.07.746. No abstract available.
- Wildi K, Cullen L, Twerenbold R, Greenslade JH, Parsonage W, Boeddinghaus J, Nestelberger T, Sabti Z, Rubini-Gimenez M, Puelacher C, Cupa J, Schumacher L, Badertscher P, Grimm K, Kozhuharov N, Stelzig C, Freese M, Rentsch K, Lohrmann J, Kloos W, Buser A, Reichlin T, Pickering JW, Than M, Mueller C. Direct Comparison of 2 Rule-Out Strategies for Acute Myocardial Infarction: 2-h Accelerated Diagnostic Protocol vs 2-h Algorithm. Clin Chem. 2017 Jul;63(7):1227-1236. doi: 10.1373/clinchem.2016.268359. Epub 2017 May 17.
- Boeddinghaus J, Nestelberger T, Twerenbold R, Wildi K, Badertscher P, Cupa J, Burge T, Machler P, Corbiere S, Grimm K, Gimenez MR, Puelacher C, Shrestha S, Flores Widmer D, Fuhrmann J, Hillinger P, Sabti Z, Honegger U, Schaerli N, Kozhuharov N, Rentsch K, Miro O, Lopez B, Martin-Sanchez FJ, Rodriguez-Adrada E, Morawiec B, Kawecki D, Ganovska E, Parenica J, Lohrmann J, Kloos W, Buser A, Geigy N, Keller DI, Osswald S, Reichlin T, Mueller C. Direct Comparison of 4 Very Early Rule-Out Strategies for Acute Myocardial Infarction Using High-Sensitivity Cardiac Troponin I. Circulation. 2017 Apr 25;135(17):1597-1611. doi: 10.1161/CIRCULATIONAHA.116.025661. Epub 2017 Mar 10.
- Hillinger P, Twerenbold R, Wildi K, Rubini Gimenez M, Jaeger C, Boeddinghaus J, Nestelberger T, Grimm K, Reichlin T, Stallone F, Puelacher C, Sabti Z, Kozhuharov N, Honegger U, Ballarino P, Miro O, Denhaerynck K, Ekrem T, Kohler C, Bingisser R, Osswald S, Mueller C. Gender-specific uncertainties in the diagnosis of acute coronary syndrome. Clin Res Cardiol. 2017 Jan;106(1):28-37. doi: 10.1007/s00392-016-1020-y. Epub 2016 Jul 12.
- Twerenbold R, Jaeger C, Rubini Gimenez M, Wildi K, Reichlin T, Nestelberger T, Boeddinghaus J, Grimm K, Puelacher C, Moehring B, Pretre G, Schaerli N, Campodarve I, Rentsch K, Steuer S, Osswald S, Mueller C. Impact of high-sensitivity cardiac troponin on use of coronary angiography, cardiac stress testing, and time to discharge in suspected acute myocardial infarction. Eur Heart J. 2016 Nov 21;37(44):3324-3332. doi: 10.1093/eurheartj/ehw232. Epub 2016 Jun 29.
- Parsonage WA, Mueller C, Greenslade JH, Wildi K, Pickering J, Than M, Aldous S, Boeddinghaus J, Hammett CJ, Hawkins T, Nestelberger T, Reichlin T, Reidt S, Rubin Gimenez M, Tate JR, Twerenbold R, Ungerer JP, Cullen L. Validation of NICE diagnostic guidance for rule out of myocardial infarction using high-sensitivity troponin tests. Heart. 2016 Aug 15;102(16):1279-86. doi: 10.1136/heartjnl-2016-309270. Epub 2016 Jun 10.
- Abacherli R, Isaksen J, Schmid R, Leber R, Schmid HJ, Generali G. Digital DC-Reconstruction of AC-Coupled Electrophysiological Signals with a Single Inverting Filter. PLoS One. 2016 Mar 3;11(3):e0150207. doi: 10.1371/journal.pone.0150207. eCollection 2016.
- Hillinger P, Twerenbold R, Jaeger C, Wildi K, Reichlin T, Rubini Gimenez M, Engels U, Miro O, Boeddinghaus J, Puelacher C, Nestelberger T, Rothlisberger M, Ernst S, Rentsch K, Mueller C. Optimizing Early Rule-Out Strategies for Acute Myocardial Infarction: Utility of 1-Hour Copeptin. Clin Chem. 2015 Dec;61(12):1466-74. doi: 10.1373/clinchem.2015.242743. Epub 2015 Aug 31.
- Twerenbold R, Wildi K, Jaeger C, Gimenez MR, Reiter M, Reichlin T, Walukiewicz A, Gugala M, Krivoshei L, Marti N, Moreno Weidmann Z, Hillinger P, Puelacher C, Rentsch K, Honegger U, Schumacher C, Zurbriggen F, Freese M, Stelzig C, Campodarve I, Bassetti S, Osswald S, Mueller C. Optimal Cutoff Levels of More Sensitive Cardiac Troponin Assays for the Early Diagnosis of Myocardial Infarction in Patients With Renal Dysfunction. Circulation. 2015 Jun 9;131(23):2041-50. doi: 10.1161/CIRCULATIONAHA.114.014245. Epub 2015 May 6.
- Wildi K, Gimenez MR, Twerenbold R, Reichlin T, Jaeger C, Heinzelmann A, Arnold C, Nelles B, Druey S, Haaf P, Hillinger P, Schaerli N, Kreutzinger P, Tanglay Y, Herrmann T, Moreno Weidmann Z, Krivoshei L, Freese M, Stelzig C, Puelacher C, Rentsch K, Osswald S, Mueller C. Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin. Circulation. 2015 Jun 9;131(23):2032-40. doi: 10.1161/CIRCULATIONAHA.114.014129. Epub 2015 May 6.
- Reichlin T, Twerenbold R, Wildi K, Gimenez MR, Bergsma N, Haaf P, Druey S, Puelacher C, Moehring B, Freese M, Stelzig C, Krivoshei L, Hillinger P, Jager C, Herrmann T, Kreutzinger P, Radosavac M, Weidmann ZM, Pershyna K, Honegger U, Wagener M, Vuillomenet T, Campodarve I, Bingisser R, Miro O, Rentsch K, Bassetti S, Osswald S, Mueller C. Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay. CMAJ. 2015 May 19;187(8):E243-E252. doi: 10.1503/cmaj.141349. Epub 2015 Apr 13.
- Rubini Gimenez M, Twerenbold R, Jaeger C, Schindler C, Puelacher C, Wildi K, Reichlin T, Haaf P, Merk S, Honegger U, Wagener M, Druey S, Schumacher C, Krivoshei L, Hillinger P, Herrmann T, Campodarve I, Rentsch K, Bassetti S, Osswald S, Mueller C. One-hour rule-in and rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I. Am J Med. 2015 Aug;128(8):861-870.e4. doi: 10.1016/j.amjmed.2015.01.046. Epub 2015 Mar 31.
- Wildi K, Cuculi F, Twerenbold R, Marxer T, Rubini Gimenez M, Reichlin T, Haaf P, Monsch R, Marsch S, Hunziker P, Bingisser R, Osswald S, Erne P, Mueller C. Incidence and timing of serious arrhythmias after early revascularization in non ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2015 Aug;4(4):359-64. doi: 10.1177/2048872614557230. Epub 2014 Oct 27.
- Rubini Gimenez M, Reiter M, Twerenbold R, Reichlin T, Wildi K, Haaf P, Wicki K, Zellweger C, Hoeller R, Moehring B, Sou SM, Mueller M, Denhaerynck K, Meller B, Stallone F, Henseler S, Bassetti S, Geigy N, Osswald S, Mueller C. Sex-specific chest pain characteristics in the early diagnosis of acute myocardial infarction. JAMA Intern Med. 2014 Feb 1;174(2):241-9. doi: 10.1001/jamainternmed.2013.12199.
- Rubini Gimenez M, Hoeller R, Reichlin T, Zellweger C, Twerenbold R, Reiter M, Moehring B, Wildi K, Mosimann T, Mueller M, Meller B, Hochgruber T, Ziller R, Sou SM, Murray K, Sakarikos K, Ernst S, Gea J, Campodarve I, Vilaplana C, Haaf P, Steuer S, Minners J, Osswald S, Mueller C. Rapid rule out of acute myocardial infarction using undetectable levels of high-sensitivity cardiac troponin. Int J Cardiol. 2013 Oct 9;168(4):3896-901. doi: 10.1016/j.ijcard.2013.06.049. Epub 2013 Jul 20.
- Balmelli C, Meune C, Twerenbold R, Reichlin T, Rieder S, Drexler B, Rubini MG, Mosimann T, Reiter M, Haaf P, Mueller M, Ernst S, Ballarino P, Alafify AA, Zellweger C, Wildi K, Moehring B, Vilaplana C, Bernhard D, Merk S, Ebmeyer S, Freidank H, Osswald S, Mueller C. Comparison of the performances of cardiac troponins, including sensitive assays, and copeptin in the diagnostic of acute myocardial infarction and long-term prognosis between women and men. Am Heart J. 2013 Jul;166(1):30-7. doi: 10.1016/j.ahj.2013.03.014. Epub 2013 Apr 30.
- Hoeller R, Rubini Gimenez M, Reichlin T, Twerenbold R, Zellweger C, Moehring B, Wildi K, Freese M, Stelzig C, Hartmann B, Stoll M, Mosimann T, Reiter M, Haaf P, Mueller M, Meller B, Hochgruber T, Balmelli C, Sou SM, Murray K, Freidank H, Steuer S, Minners J, Osswald S, Mueller C. Normal presenting levels of high-sensitivity troponin and myocardial infarction. Heart. 2013 Nov;99(21):1567-72. doi: 10.1136/heartjnl-2013-303643. Epub 2013 Apr 19.
- Cullen L, Mueller C, Parsonage WA, Wildi K, Greenslade JH, Twerenbold R, Aldous S, Meller B, Tate JR, Reichlin T, Hammett CJ, Zellweger C, Ungerer JPJ, Rubini Gimenez M, Troughton R, Murray K, Brown AFT, Mueller M, George P, Mosimann T, Flaws DF, Reiter M, Lamanna A, Haaf P, Pemberton CJ, Richards AM, Chu K, Reid CM, Peacock WF, Jaffe AS, Florkowski C, Deely JM, Than M. Validation of high-sensitivity troponin I in a 2-hour diagnostic strategy to assess 30-day outcomes in emergency department patients with possible acute coronary syndrome. J Am Coll Cardiol. 2013 Oct 1;62(14):1242-1249. doi: 10.1016/j.jacc.2013.02.078. Epub 2013 Apr 10.
- Reichlin T, Twerenbold R, Maushart C, Reiter M, Moehring B, Schaub N, Balmelli C, Rubini Gimenez M, Hoeller R, Sakarikos K, Drexler B, Haaf P, Osswald S, Mueller C. Risk stratification in patients with unstable angina using absolute serial changes of 3 high-sensitive troponin assays. Am Heart J. 2013 Mar;165(3):371-8.e3. doi: 10.1016/j.ahj.2012.11.010. Epub 2013 Jan 24.
- Haaf P, Twerenbold R, Reichlin T, Faoro J, Reiter M, Meune C, Steuer S, Bassetti S, Ziller R, Balmelli C, Campodarve I, Zellweger C, Kilchenmann A, Irfan A, Papassotiriou J, Drexler B, Mueller C. Mid-regional pro-adrenomedullin in the early evaluation of acute chest pain patients. Int J Cardiol. 2013 Sep 30;168(2):1048-55. doi: 10.1016/j.ijcard.2012.10.025. Epub 2012 Nov 27.
- Reichlin T, Twerenbold R, Reiter M, Steuer S, Bassetti S, Balmelli C, Winkler K, Kurz S, Stelzig C, Freese M, Drexler B, Haaf P, Zellweger C, Osswald S, Mueller C. Introduction of high-sensitivity troponin assays: impact on myocardial infarction incidence and prognosis. Am J Med. 2012 Dec;125(12):1205-1213.e1. doi: 10.1016/j.amjmed.2012.07.015.
- Haaf P, Drexler B, Reichlin T, Twerenbold R, Reiter M, Meissner J, Schaub N, Stelzig C, Freese M, Heinzelmann A, Meune C, Balmelli C, Freidank H, Winkler K, Denhaerynck K, Hochholzer W, Osswald S, Mueller C. High-sensitivity cardiac troponin in the distinction of acute myocardial infarction from acute cardiac noncoronary artery disease. Circulation. 2012 Jul 3;126(1):31-40. doi: 10.1161/CIRCULATIONAHA.112.100867. Epub 2012 May 23.
- Potocki M, Reichlin T, Thalmann S, Zellweger C, Twerenbold R, Reiter M, Steuer S, Bassetti S, Drexler B, Stelzig C, Freese M, Winkler K, Haaf P, Balmelli C, Hochholzer W, Osswald S, Mueller C. Diagnostic and prognostic impact of copeptin and high-sensitivity cardiac troponin T in patients with pre-existing coronary artery disease and suspected acute myocardial infarction. Heart. 2012 Apr;98(7):558-65. doi: 10.1136/heartjnl-2011-301269. Epub 2012 Feb 15.
- Schaub N, Reichlin T, Meune C, Twerenbold R, Haaf P, Hochholzer W, Niederhauser N, Bosshard P, Stelzig C, Freese M, Reiter M, Gea J, Buser A, Mebazaa A, Osswald S, Mueller C. Markers of plaque instability in the early diagnosis and risk stratification of acute myocardial infarction. Clin Chem. 2012 Jan;58(1):246-56. doi: 10.1373/clinchem.2011.172940. Epub 2011 Nov 4.
- Reiter M, Twerenbold R, Reichlin T, Benz B, Haaf P, Meissner J, Hochholzer W, Stelzig C, Freese M, Heinisch C, Balmelli C, Drexler B, Freidank H, Winkler K, Campodarve I, Gea J, Mueller C. Early diagnosis of acute myocardial infarction in patients with pre-existing coronary artery disease using more sensitive cardiac troponin assays. Eur Heart J. 2012 Apr;33(8):988-97. doi: 10.1093/eurheartj/ehr376. Epub 2011 Oct 31.
- Hochholzer W, Reichlin T, Twerenbold R, Stelzig C, Hochholzer K, Meissner J, Haaf P, Schaub N, Steuer S, Bassetti S, Reiter M, Roost K, Freidank H, Winkler K, Mueller C. Incremental value of high-sensitivity cardiac troponin T for risk prediction in patients with suspected acute myocardial infarction. Clin Chem. 2011 Sep;57(9):1318-26. doi: 10.1373/clinchem.2011.162073. Epub 2011 Jul 19.
- Reichlin T, Irfan A, Twerenbold R, Reiter M, Hochholzer W, Burkhalter H, Bassetti S, Steuer S, Winkler K, Peter F, Meissner J, Haaf P, Potocki M, Drexler B, Osswald S, Mueller C. Utility of absolute and relative changes in cardiac troponin concentrations in the early diagnosis of acute myocardial infarction. Circulation. 2011 Jul 12;124(2):136-45. doi: 10.1161/CIRCULATIONAHA.111.023937. Epub 2011 Jun 27.
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- Hochholzer W, Reichlin T, Stelzig C, Hochholzer K, Meissner J, Breidthardt T, Reiter M, Duehsler B, Freidank H, Winkler K, Twerenbold R, Mueller C. Impact of soluble fms-like tyrosine kinase-1 and placental growth factor serum levels for risk stratification and early diagnosis in patients with suspected acute myocardial infarction. Eur Heart J. 2011 Feb;32(3):326-35. doi: 10.1093/eurheartj/ehq429. Epub 2010 Dec 7.
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- Reichlin T, Hochholzer W, Stelzig C, Laule K, Freidank H, Morgenthaler NG, Bergmann A, Potocki M, Noveanu M, Breidthardt T, Christ A, Boldanova T, Merki R, Schaub N, Bingisser R, Christ M, Mueller C. Incremental value of copeptin for rapid rule out of acute myocardial infarction. J Am Coll Cardiol. 2009 Jun 30;54(1):60-8. doi: 10.1016/j.jacc.2009.01.076.
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- Haller PM, Boeddinghaus J, Neumann JT, Sorensen NA, Hartikainen TS, Gossling A, Nestelberger T, Twerenbold R, Lehmacher J, Keller T, Zeller T, Blankenberg S, Mueller C, Westermann D. Performance of the ESC 0/1-h and 0/3-h Algorithm for the Rapid Identification of Myocardial Infarction Without ST-Elevation in Patients With Diabetes. Diabetes Care. 2020 Feb;43(2):460-467. doi: 10.2337/dc19-1327. Epub 2019 Dec 16.
- Neumann JT, Twerenbold R, Ojeda F, Sorensen NA, Chapman AR, Shah ASV, Anand A, Boeddinghaus J, Nestelberger T, Badertscher P, Mokhtari A, Pickering JW, Troughton RW, Greenslade J, Parsonage W, Mueller-Hennessen M, Gori T, Jernberg T, Morris N, Liebetrau C, Hamm C, Katus HA, Munzel T, Landmesser U, Salomaa V, Iacoviello L, Ferrario MM, Giampaoli S, Kee F, Thorand B, Peters A, Borchini R, Jorgensen T, Soderberg S, Sans S, Tunstall-Pedoe H, Kuulasmaa K, Renne T, Lackner KJ, Worster A, Body R, Ekelund U, Kavsak PA, Keller T, Lindahl B, Wild P, Giannitsis E, Than M, Cullen LA, Mills NL, Mueller C, Zeller T, Westermann D, Blankenberg S; COMPASS-MI Study Group. Application of High-Sensitivity Troponin in Suspected Myocardial Infarction. N Engl J Med. 2019 Jun 27;380(26):2529-2540. doi: 10.1056/NEJMoa1803377.
- Kaier TE, Twerenbold R, Puelacher C, Marjot J, Imambaccus N, Boeddinghaus J, Nestelberger T, Badertscher P, Sabti Z, Gimenez MR, Wildi K, Hillinger P, Grimm K, Loeffel S, Shrestha S, Widmer DF, Cupa J, Kozhuharov N, Miro O, Martin-Sanchez FJ, Morawiec B, Rentsch K, Lohrmann J, Kloos W, Osswald S, Reichlin T, Weber E, Marber M, Mueller C. Direct Comparison of Cardiac Myosin-Binding Protein C With Cardiac Troponins for the Early Diagnosis of Acute Myocardial Infarction. Circulation. 2017 Oct 17;136(16):1495-1508. doi: 10.1161/CIRCULATIONAHA.117.028084. Epub 2017 Sep 26.
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- Dugar F, Lopez-Ayala P, Koechlin L, Bima P, Glaeser J, Spagnuolo C, Crisanti L, Wick C, Wildi K, Kaplan E, Strebel I, Miro O, Martin-Sanchez FJ, Christ M, Morawiec B, Gimenez MR, Nestelberger T, Boeddinghaus J, Mueller C; APACE investigators. Diagnostic and prognostic utility of endocan in suspected myocardial infarction: an international cohort study. Clin Chim Acta. 2026 Jan 1;578:120510. doi: 10.1016/j.cca.2025.120510. Epub 2025 Jul 25.
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- Albus M, Zimmermann T, Median D, Rumora K, Isayeva G, Amrein M, Schaefer I, Walter J, Michel E, Hure G, Strebel I, Caobelli F, Haaf P, Frey SM, Mueller C, Zellweger MJ. Combining anatomical and biochemical markers in the detection and risk stratification of coronary artery disease. Eur Heart J Cardiovasc Imaging. 2024 Aug 26;25(9):1197-1205. doi: 10.1093/ehjci/jeae093.
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- Fernandez-Cisnal A, Lopez-Ayala P, Valero E, Koechlin L, Catarrala A, Boeddinghaus J, Noceda J, Nestelberger T, Miro O, Julio N, Mueller C, Sanchis J. Derivation and external validation of machine-learning models for risk stratification in chest pain with normal troponin. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):743-752. doi: 10.1093/ehjacc/zuad089.
- Meier M, Boeddinghaus J, Nestelberger T, Koechlin L, Lopez-Ayala P, Wussler D, Walter JE, Zimmermann T, Badertscher P, Wildi K, Gimenez MR, Puelacher C, Glarner N, Magni J, Miro O, Martin-Sanchez FJ, Kawecki D, Keller DI, Gualandro DM, Twerenbold R, Nickel CH, Bingisser R, Mueller C; APACE investigators. Comparing the utility of clinical risk scores and integrated clinical judgement in patients with suspected acute coronary syndrome. Eur Heart J Acute Cardiovasc Care. 2023 Oct 25;12(10):693-702. doi: 10.1093/ehjacc/zuad081.
- Boeddinghaus J, Nestelberger T, Koechlin L, Lopez-Ayala P, Wussler D, Mais M, Zwimpfer L, Zimmermann T, Wildi K, Gimenez MR, Strebel I, Miro O, Martin-Sanchez FJ, Parenica J, Keller DI, Gualandro DM, Nickel CH, Bingisser R, Christ M, Mueller C; APACE investigators. Association of accompanying dyspnoea with diagnosis and outcome of patients presenting with acute chest discomfort. Eur Heart J Acute Cardiovasc Care. 2023 May 4;12(5):283-295. doi: 10.1093/ehjacc/zuad026.
- Koechlin L, Strebel I, Zimmermann T, Nestelberger T, Walter J, Lopez-Ayala P, Boeddinghaus J, Shrestha S, Arslani K, Stefanelli S, Reuthebuch B, Wussler D, Ratmann PD, Christ M, Badertscher P, Wildi K, Gimenez MR, Gualandro DM, Miro O, Fuenzalida C, Martin-Sanchez FJ, Kawecki D, Burgler F, Keller DI, Abacherli R, Reuthebuch O, Eckstein FS, Twerenbold R, Reichlin T, Mueller C; APACE investigators. Hyperacute T Wave in the Early Diagnosis of Acute Myocardial Infarction. Ann Emerg Med. 2023 Aug;82(2):194-202. doi: 10.1016/j.annemergmed.2022.12.003. Epub 2023 Feb 10.
- Ratmann PD, Boeddinghaus J, Nestelberger T, Lopez-Ayala P, Hure G, Gehrke J, Koechlin L, Wildi K, Mueller P, Bima P, Wussler D, Gisler N, Miro O, Martin-Sanchez FJ, Christ M, Gualandro DM, Twerenbold R, Gimenez MR, Keller DI, Buser A, Mueller C; APACE Investigators. Extending the no objective testing rules to patients triaged by the European Society of Cardiology 0/1-hour algorithms. Eur Heart J Acute Cardiovasc Care. 2022 Nov 30;11(11):834-840. doi: 10.1093/ehjacc/zuac120.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年4月1日
初级完成 (实际的)
2025年3月2日
研究完成 (实际的)
2025年12月1日
研究注册日期
首次提交
2007年5月7日
首先提交符合 QC 标准的
2007年5月7日
首次发布 (估计的)
2007年5月8日
研究记录更新
最后更新发布 (估计的)
2025年12月15日
上次提交的符合 QC 标准的更新
2025年12月5日
最后验证
2025年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.