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Implementing the 6th Generation Cardiac Troponin T

2026年11月10日更新者：Rasmus Bo Hasselbalch

Implementing the 6th Generation Cardiac Troponin T: A Stepped Wedged Cluster-randomized Trial

This study will test how a new blood test for troponin T can be introduced into routine hospital care in Denmark and Norway. The study will look at whether the new test helps doctors assess and treat patients with possible heart problems more effectively and safely.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Background Cardiac troponin (cTn) is the key biomarker for diagnosing myocardial infarction (MI). There are two cardiac specific isoforms of cTn, cTnT and cTnI, considered equal in contemporary guidelines. About half of hospitals in Denmark and two thirds of Norwegian providing acute cardiovascular care use cTnT from Roche Diagnostics in routine practice. An improved version of this assay has recently been developed, named the 6th generation cTnT. This novel assay expected to be implemented worldwide within the next years, but there is still limited data comparing it with the previous generation of cTnT. We aim to implement and test the use of the new 6th generation cTnT assay in Danish-Norwegian collaborative, stepped-wedge trial.

Methods This will be a stepped-wedged cluster-randomized implementation study investigating the medical and practical real-life consequences of switching from the 5th to the 6th generation cTnT assay in routine use. All hospitals using cTnT in either Denmark or Norway will be invited to participate in the study. Centers will be randomized to an implementation date. The hospital should switch assay within 1-15 days after the applicable deadline. Following admission, patients will be followed through national registries.

Assay specifics The 6th generation cTnT assay is expected to have a limit of quantification at 1.5 ng/L and an analyti-cal variation of 3% at the 99th upper reference limit. All sites will use the reference values estimated in the assay insert.

Timeline There will be 7 centers in Denmark and 4 centers in Norway in the study. Data collection will begin on the 1st of August 2026 with the first centers expected to switch on the 1st of October 2026. This will mean that the final center will switch on the 1st of August 2027, and the primary results will be available by the end of March 2028. Each laboratory will receive a plan for local analytical verification of the assay.

Collaboration The study is designed and performed as a collaborative effort between Danish and Norwegian re-searchers and led by Kristin Aakre, Rasmus Bo Hasselbalch, Torbjørn Omland and Kasper Iversen. All centers will be invited to participate and contributors fulfilling Vancouver criteria will be invited as authors of any publications. This implementation study will be performed in collaboration with the national societies of clinical biochemistry.

Ethics The project has been presented to the Danish regional ethics committee and is expected to receive a waiver for patient consent in this study. A similar ethical waiver has been given in Norway. The data will follow GDPR guidelines regarding data protection.

Power calculations In a stepped wedge design the period between successive interventions (i.e. stops) is the main design parameter. The study is designed as a primary superiority trial. Given 11 centers and an ex-pected event rate of about 4% and each center including between 200 and 800 patients a month, the study would have above 90% power to show an absolute risk difference of 0.8%. This calcula-tion was performed in collaboration with Professor Theis Lange.

研究类型

介入性

注册 (估计的)

22600

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。

学习联系方式

姓名：Rasmus B Hasselbalch, MD, PhD
电话号码：+45 38683868
邮箱：rasmus.bo.hasselbalch@regionh.dk

研究联系人备份

姓名：Kristin Aakre, MD, PhD
邮箱：kristin.moberg.aakre@helse-bergen.no

学习地点

丹麦
- - Herlev、丹麦、2730
    - 尚未招聘
    - Copenhagen University Hospital - Herlev and Gentofte Hospital
    - 接触：
      
      Kasper Iversen, Md, Dmsc
      
      电话号码：+45 38683868
      
      邮箱：Kasper.karmark.iversen@regionh.dk
  - Horsens、丹麦、8700
    - 尚未招聘
    - Regionshospitalet Horsens
    - 接触：
      
      Rasmus Hasselbalch, Md, PhD
      
      电话号码：+45 35453545
      
      邮箱：rasmus.bo.hasselbalch@regionh.dk
  - Kolding、丹麦、6000
    - 尚未招聘
    - Sygehus Lillebælt
    - 接触：
      
      Rasmus Hasselbalch, Md, PhD
      
      电话号码：35453545
      
      邮箱：rasmus.bo.hasselbalch@regionh.dk
  - København NV、丹麦、2400
    - 尚未招聘
    - Copenhagen University Hospital - Bispebjerg
    - 接触：
      
      Rasmus Hasselbalch, Md, PhD
      
      电话号码：+45 35453545
      
      邮箱：rasmus.bo.hasselbalch@regionh.dk
  - København Ø、丹麦、2100
    - 尚未招聘
    - Copenhagen University Hospital - Rigshospitalet
    - 接触：
      
      Rasmus Hasselbalch
      
      电话号码：+45 34453545
      
      邮箱：rasmus.bo.hasselbalch@regionh.dk
  - Odense、丹麦、5000
    - 招聘中
    - Odense Universitetshospital
    - 接触：
      
      Rasmus Hasselbalch, Md, PhD
      
      电话号码：+45 35453545
      
      邮箱：rasmus.bo.hasselbalch@regionh.dk
  - Svendborg、丹麦、5700
    - 尚未招聘
    - Odense Universitetshospital Svendborg Sygehus
    - 接触：
      
      Rasmus Hasselbalch, Md, PhD
      
      电话号码：+45 35453545
      
      邮箱：rasmus.bo.hasselbalch@regionh.dk
  - Sønderborg、丹麦、6400
    - 尚未招聘
    - Sygehus Sønderjylland
    - 接触：
      
      Rasmus Hasselbalch, Md, PhD
      
      电话号码：+45 35453545
      
      邮箱：rasmus.bo.hasselbalch@regionh.dk
挪威
- - Bergen、挪威、5009
    - 尚未招聘
    - Haraldsplass Diakonale sykehus
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Haukeland、挪威、5009
    - 尚未招聘
    - Haukeland Universitetshospital
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Hønefoss、挪威、3511
    - 尚未招聘
    - Vestre Viken HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Kristiansand、挪威、4604
    - 尚未招聘
    - Sørlandet Sykehus HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Lørenskog、挪威、1478
    - 尚未招聘
    - Akershus Universitetssykehus HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Nydalen、挪威、4950
    - 尚未招聘
    - Oslo Universitetssykehus HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Oslo、挪威、0370
    - 尚未招聘
    - Diakonhjemmet Sykehus
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Oslo、挪威、0456
    - 尚未招聘
    - Lovisenberg Sykehus
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Stavanger、挪威、4011
    - 尚未招聘
    - Helse Stavanger HF - Stavanger universitetssjukehus
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Tromsø、挪威、9019
    - 招聘中
    - Universitetssykehuset Nord-Norge HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Trondheim、挪威、7030
    - 尚未招聘
    - St. Olavs Hospital HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Tønsberg、挪威、3103
    - 尚未招聘
    - Sykehuset i Vestfold HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Ålesund、挪威、6017
    - 尚未招聘
    - Ålesund sjukehus
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：+47 55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no
  - Ålesund、挪威、6026
    - 招聘中
    - Helse Møre og Romsdal HF
    - 接触：
      
      Kristin Aakre, Md, PhD
      
      电话号码：55975000
      
      邮箱：kristin.moberg.aakre@helse-bergen.no

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

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Admitted at any of the participating hospitals
At least one measurement of cardiac troponin T as a part of routine care in the ED

Exclusion Criteria:

Readmission within the study followup

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

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：5th generation cardiac troponin T arm Treatment is based on the use of the 5th generation troponin T assay	诊断测试：Standard arm (5th generation of troponin T) Regular use of the 5th generation troponin T assay
实验性的：6th generation cardiac troponin T arm Treatment is based on the use of the new 6th generation troponin T assay	诊断测试：Use of the 6th generation of cardiac troponin T assay The change will be in a stepped-wedge cluster randomised design

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
Composite endpoint of death from any cause and MI, or revascularization within 6 months after admission (PCI and CABG). 大体时间：6 months	This will exclude events during the index admission	6 months

次要结果测量

结果测量	措施说明	大体时间
The incidence of fatal and non-fatal MI (I21, I22) 大体时间：At the time of hospital discharge (Day 0)	All events during admission	At the time of hospital discharge (Day 0)
Unstable angina pectoris (I20.0) 大体时间：At the time of hospital discharge (Day 0)	Unstable angina diagnosed during admission	At the time of hospital discharge (Day 0)
Invasive coronary angiography 大体时间：Up to 30 days following discharge	Use of invasive coronary angiography during admission, or planned under index admission	Up to 30 days following discharge
Coronary CT angiography 大体时间：Up to 30 days following discharge	Use of coronary CT angiography during admission or planned at index admission	Up to 30 days following discharge
The length of stay 大体时间：At the time of hospital discharge (Day 0)	The length of stay during index admission	At the time of hospital discharge (Day 0)
Readmissions within 30 days 大体时间：Within 30 days of index admission	The rate of readmission following index admission within 30 days for any cardiovascular cause	Within 30 days of index admission

其他结果措施

结果测量	措施说明	大体时间
Percentage discharged from the hospital within 6 hours 大体时间：At the time of hospital discharge (Day 0)	Percentage discharged from the hospital within 6 hours (if data can be made available)	At the time of hospital discharge (Day 0)

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。

赞助

Rasmus Bo Hasselbalch

合作者

University of Bergen

Haukeland University Hospital

调查人员

首席研究员：Kristin Aakre, MD, PhD、Haukeland University Hospital
首席研究员：Kasper Iversen, MD, Dmsc、Copenhagen University Hospital - Herlev and Gentofte Hospital

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)

2026年8月1日

初级完成 (估计的)

2028年3月31日

研究完成 (估计的)

2028年7月31日

研究注册日期

首次提交

2026年11月4日

首先提交符合 QC 标准的

2026年11月10日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

Implementing the 6th Generation Cardiac Troponin T