排除急性心肌梗死的人群和性别特异性肌钙蛋白截断值的研究 (DANSPOT)
2026年8月24日 更新者：Kasper Iversen、Herlev Hospital
排除急性心肌梗死的人群和性别特异性肌钙蛋白临界值的随机临床试验 (RCT) - 丹麦人群和性别特异性肌钙蛋白临界值研究
急性心肌梗死 (MI) 的定义是心肌肌钙蛋白升高和/或降低，在出现心肌缺血症状或临床证据的情况下，至少有一个值高于第 99 个百分位参考上限 (URL)。 URL 基于对健康参考人群的测量。 目前，丹麦医院使用性别制服制造商提供的肌钙蛋白的第 99 个百分位 URL 作为男性和女性急性 MI 的诊断截止值。 据报道，健康男性的肌钙蛋白水平是健康女性的两倍，这表明使用统一的肌钙蛋白 URL 可能导致女性对急性 MI 的诊断不足，并可能导致男性过度诊断。
DANSPOT 研究的目的是评估将国际指南建议的肌钙蛋白性别特异性第 99 个百分位 URL 实施到临床实践中对患有急性 MI 的男性和女性的诊断、治疗和结果的临床效果。
首先，为了根据健康的丹麦参考人群确定肌钙蛋白的性别特异性第 99 个百分位 URL，使用一种肌钙蛋白 T 测定和四种肌钙蛋白 I 测定分析来自丹麦献血者的血液样本。 其次，DANSPOT 研究是一项采用“阶梯楔形”设计的全国性整群随机试验，丹麦所有 22 家医院实验室和相关心脏病科室均参与。 每隔一个月，22 个中心中的每一个都被随机分配，从目前应用的统一的肌钙蛋白第 99 个百分位 URL 转变为我们新确定的人群和特定性别的第 99 个百分位 URL。 首次入院后，丹麦登记处对每位患者进行了为期 12 个月的随访。
DANSPOT 研究的假设是，针对肌钙蛋白实施人群和性别特异性第 99 位 URL，将确保正确的患者接受正确的治疗。 研究人员期望检测出更多患有急性心肌梗死的女性，理论上可以更准确地诊断和治疗患有急性心肌梗死的女性和男性。
研究概览
地位
完全的
条件
详细说明
目前在急性心肌梗死 (MI) 的诊断中使用非性别特异性诊断截止水平的肌钙蛋白导致女性对急性 MI 的诊断不足和男性的过度诊断。 本研究的目的是通过在全国范围内随机临床实施人口和性别特异性临界值来记录这一点。
冠状动脉疾病 (CAD) 是全球男性和女性死亡的主要原因。 最新的共识声明将心肌梗死定义为 1) 心肌肌钙蛋白升高和/或下降 2) 在 3) 心肌缺血的症状或临床证据的情况下至少有一个值高于第 99 个百分位参考上限 (URL)。 因此，心肌肌钙蛋白水平在一般诊断检查中起着关键作用。 目前，由健康参考人群中第 99 个百分位数的心肌肌钙蛋白定义的统一制造商提供的 URL 在丹麦医院中被用作男性和女性急性 MI 的诊断截止值。
与健康男性相比，健康女性的心肌肌钙蛋白水平较低，即男性的心肌肌钙蛋白水平是男性的两倍。 在此基础上，对心肌肌钙蛋白使用统一的第 99 个百分位 URL 的临床应用——即对男性和女性应用相同的诊断水平——可能导致女性对急性 MI 的系统性诊断不足，并可能导致对女性急性 MI 的过度诊断。男人。 因此，国际心脏病学会最近的指南现在推荐使用心肌肌钙蛋白的性别特异性第 99 个百分位数 URL，但这仍有待引入临床实践。
丹麦医院目前使用的心肌肌钙蛋白的第 99 个百分位 URL 由每个特定检测的制造商根据制造商收集的健康参考人群的血液样本提供。 研究表明，第 99 个百分位值取决于患者性别以及所选参考人群和这些研究中使用的“健康”定义。 众所周知，第 99 个百分位 URL 应该来自本地参考人群。 该建议从未在丹麦实施。
该研究的总体目的是评估在丹麦实施针对心肌肌钙蛋白的人群和性别特异性 99% URL 的临床效果。
为了根据健康的丹麦参考人群确定肌钙蛋白的性别特异性第 99 个百分位 URL，使用一种肌钙蛋白 T 测定和四种肌钙蛋白 I 测定分析了来自健康丹麦献血者的血液样本。 其次，DANSPOT 研究是一项采用“阶梯楔形”设计的全国性整群随机试验，丹麦所有 22 家医院实验室和相关心脏病科室均参与。 每隔一个月，22 个中心中的每一个都被随机分配，从目前应用的统一的肌钙蛋白第 99 个百分位 URL 转变为我们新确定的人群和特定性别的第 99 个百分位 URL。 首次入院后，丹麦登记处对每位患者进行了为期 12 个月的随访。
肌钙蛋白的性别特异性第 99 个百分位 URL 的临床意义研究很少，并且出于同样的原因尚未在丹麦或许多其他国家实施。 DANSPOT 研究的基本假设是，针对肌钙蛋白实施针对特定人群和性别的第 99 位 URL，将确保正确的患者接受正确的治疗。 研究人员期望检测出更多患有急性心肌梗死的女性，理论上可以更准确地诊断和治疗患有急性心肌梗死的女性和男性。 这将是在丹麦以及国际上按照专业心脏病学会指南中的建议实施心肌肌钙蛋白性别特异性截断值的指南定义。
研究类型
介入性
注册 (实际的)
5175
阶段
- 不适用
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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Aabenraa、丹麦、6200
- Hospital of Southern Jutland
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Aalborg、丹麦、9000
- Aalborg University Hospital
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Aarhus、丹麦、8000
- Aarhus University Hospital
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Bispebjerg、丹麦、2400
- Bispebjerg & Frederiksberg Hospital
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Copenhagen Ø、丹麦、2100
- Rigshospitalet (Blegdamsvej)
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Esbjerg、丹麦、6700
- Sydvestjysk Sygehus
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Glostrup Municipality、丹麦、2600
- Glostrup University Hospital
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Gødstrup、丹麦、7400
- Gødstrup Regional Hospital
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Herlev、丹麦、2730
- Herlev & Gentofte Hospital
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Hillerød、丹麦、3400
- C Torp-Pedersen
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Hjørring、丹麦、9800
- North Denmark Regional Hospital
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Holbæk、丹麦、4300
- Holbaek Sygehus
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Horsens、丹麦、8700
- Horsens Hospital
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Hvidovre、丹麦、2650
- Amager & Hvidovre Hospital
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Kolding、丹麦、6000
- Sygehus Lillebælt (Kolding Sygehus & Vejle Sygehus)
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Køge、丹麦、4600
- Zealand University Hospital
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Nykøbing Falster、丹麦、4800
- Nykøbing Falster County Hospital
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Odense、丹麦、5000
- Odense University Hospital
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Randers、丹麦、8930
- Randers Regional Hospital
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Slagelse、丹麦、4200
- Slagelse Sygehus
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Svendborg、丹麦、5700
- Svendborg Hospital
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Viborg、丹麦、8800
- Central Jutland Regional Hospital (Viborg Hospital & Silkeborg Hospital)
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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
是的
描述
纳入标准：
- 怀疑心肌梗死和肌钙蛋白测量
排除标准：
- 年龄 < 18 岁
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
- 主要用途：诊断
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：干预组 - 肌钙蛋白的新人群和性别特异性第 99 个百分位 URL
实施新的人群和特定性别的肌钙蛋白第 99 个百分位 URL，用于在登记中心使用的特定检测。
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The new population and sex-specific 99th percentile URLs will be implemented at all Danish hospitals receiving patients with chest pain for initial diagnostics for possible acute MI.
This will take place as a randomised, step-by-step introduction of population- and sex-specific 99th percentile URLs for troponin in all hospital centres, with a monthly start time interval.
Each centre is randomised to shift from the sex-uniform manufacturer-provided 99th percentile URL of cardiac troponin currently used nationwide to the new population- and sex-specific 99th percentile URLs provided by the DANSPOT study's first phase.
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无干预：Control Arm - Current sex-uniform manufacturer provided 99th percentile URL of troponin
Standard use of the current sex-uniform manufacturer-provided 99th percentile URL of troponin is utilised at Danish hospitals as a diagnostic cutoff for acute MI for both men and women
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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A composite endpoint of: 1) readmission for myocardial infarction 2) readmission for unplanned revascularisation (PCI or CABG) 3) all cause mortality All events must occur within 12 months of the first troponin measurement during the index admission
大体时间：The 12-month period starting from the first troponin measurement during the index admission.
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We will compare the occurrence of the primary outcome separately in men and women within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
For individuals included in the primary cohort, all readmissions within the 12-month follow-up period will be adjudicated by an endpoint committee to identify type 1, type 2, and type 4b myocardial infarction, as well as unplanned coronary revascularisation.
All-cause mortality will be ascertained from national patient data extracts.
For the diagnosis of type 2 infarctions, we will utilise the criteria established by Saaby et al.
Unplanned coronary revascularisation is defined as any percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) performed after discharge from the index admission, in patients without coronary angiography or cardiac CT performed or planned during the index admission, leading to planned revascularisation.
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The 12-month period starting from the first troponin measurement during the index admission.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All-cause mortality within 12 months
大体时间：Within 12 months from the first troponin measurement during the index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
All-cause mortality within follow-up will be identified through patient data extracts.
Follow-up is defined as the 12-month period starting from the first troponin measurement during the index admission.
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Within 12 months from the first troponin measurement during the index admission
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Non-fatal myocardial infarction (MI) occurring during any readmission within 12 months
大体时间：Within 12 months from the first troponin measurement during the index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Non-fatal MI during readmissions within follow-up will be identified through endpoint adjudication.
Follow-up is defined as the 12-month period starting from the first troponin measurement during the index admission.
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Within 12 months from the first troponin measurement during the index admission
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Myocardial injury occurring during the index admission
大体时间：During index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Myocardial injury during the index admission will be identified through patient data extracts.
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During index admission
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Coronary angiography or coronary computed tomography performed during the index admission
大体时间：During index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Coronary angiography and coronary computed tomography performed during the index admission will be identified through patient data extracts.
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During index admission
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Unplanned coronary revascularisation (PCI or CABG) performed during any readmission within 12 months
大体时间：Within 12 months from the first troponin measurement during the index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Unplanned coronary revascularisation during readmissions within follow-up will be identified through endpoint adjudication.
Follow-up is defined as the 12-month period starting from the first troponin measurement during the index admission.
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Within 12 months from the first troponin measurement during the index admission
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Non-fatal myocardial infarction (MI) occurring during the index admission
大体时间：During index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Non-fatal MI during the index admission will be identified through patient data extracts.
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During index admission
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Myocardial injury occurring during any readmission within 12 months
大体时间：Within 12 months from the first troponin measurement during the index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Myocardial injury during readmissions within follow-up will be identified through endpoint adjudication.
Follow-up is defined as the 12-month period starting from the first troponin measurement during the index admission.
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Within 12 months from the first troponin measurement during the index admission
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Documented initiation or continuation of guideline-directed medical therapy for myocardial infarction during the index admission
大体时间：During the index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Guideline-directed medical therapy during the index admission will be identified through patient data extracts and verified in the medical records for the indication of myocardial infarction.
Guideline-directed medical therapy is defined as treatment with acetylsalicylic acid, a P2Y12 inhibitor, and statin therapy, or appropriate alternative therapy when standard treatment is contraindicated, not tolerated, or clinically inappropriate.
Treatment classification will be based on the documented clinical indication and treatment intention.
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During the index admission
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Coronary revascularisation (PCI or CABG) performed during the index admission or planned during the index admission and subsequently performed within 3 months
大体时间：During the index admission or within 3 months of discharge
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Coronary revascularisation performed during the index admission, or planned during the index admission and subsequently performed within 3 months, will be identified using patient data extracts.
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During the index admission or within 3 months of discharge
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Coronary angiography or coronary computed tomography performed during the index admission without subsequent planned coronary revascularisation within 3 months
大体时间：During the index admission or within 3 months of discharge
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
Coronary angiography and coronary computed tomography performed during the index admission without subsequent planned coronary revascularisation within 3 months will be identified through patient data extracts.
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During the index admission or within 3 months of discharge
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Length of stay during the index admission in the primary cohort
大体时间：During index admission
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Secondary endpoints will be evaluated separately in women and men within the primary cohort before and after implementation of the new sex-specific diagnostic thresholds.
The length of stay during the index admission will be identified through patient data extracts.
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During index admission
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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。
合作者
调查人员
- 首席研究员：Kasper K Iversen, MD, DMsc、Herlev Hospital, University Hospital of Copenhagen
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
- Hasselbalch RB, Strandkjaer N, Kristensen J, Jorgensen N, Kock TO, Lange T, Ostrowski SR, Nissen J, Larsen MH, Vesterager Pedersen OB, Bor MV, Afzal S, Kamstrup PR, Dahl M, Hilsted L, Rode L, Jorgensen NR, Torp-Pedersen C, Bundgaard H, Iversen KK. Impact of age on cardiac troponin concentration among healthy individuals. Clin Biochem. 2025 Aug;138:110956. doi: 10.1016/j.clinbiochem.2025.110956. Epub 2025 Jun 11.
- Strandkjaer N, Jorgensen N, Hasselbalch RB, Kristensen J, Knudsen MSS, Kock TO, Lange T, Lindholm MG, Bruun NE, Holmvang L, Terkelsen CJ, Pedersen CK, Christensen MK, Lassen JF, Hilsted L, Ladefoged S, Nybo M, Bor MV, Dahl M, Hansen AB, Kamstrup PR, Bundgaard H, Torp-Pedersen C, Iversen KK. DANSPOT: A Multicenter Stepped-Wedge Cluster-Randomized Trial of the Reclassification of Acute Myocardial Infarction: Rationale and Study Design. J Am Heart Assoc. 2024 May 7;13(9):e033493. doi: 10.1161/JAHA.123.033493. Epub 2024 Apr 19.
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 (实际的)
2022年4月1日
初级完成 (实际的)
2025年2月28日
研究完成 (实际的)
2025年2月28日
研究注册日期
首次提交
2022年3月29日
首先提交符合 QC 标准的
2022年4月19日
首次发布 (实际的)
2022年4月20日
研究记录更新
最后更新发布 (实际的)
2026年8月26日
上次提交的符合 QC 标准的更新
2026年8月24日
最后验证
2026年8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.