HsTnT in Stable Coronary Artery Disease
Elevated High-sensitivity Cardiac Troponin T Levels in Patients With Stable Coronary Artery Disease
Coronary artery disease (CAD) is one of the leading causes of morbidity and mortality worldwide. Life threatening manifestations such as acute myocardial infarction (AMI) and sudden cardiac death are the most important causes of death in many countries. Cardiac troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for diagnosis of acute myocardial infarction by the Universal definition of myocardial infarction. Since a new generation of high-sensitivity cardiac troponin assays has become commercially available a few years ago, myocardial infarction can be detected earlier and even small AMIs, that were classified as unstable angina pectoris (UAP) with the less sensitive assays, are detectable now. On the other side, more patients with acute or chronic myocardial damage not due to AMI are identified now. Thereby, the reason for elevated troponin levels should be sought actively, because high troponin levels were associated with adverse outcome - independent of the underlying pathomechanism. The reasons for troponin elevations in patients with stable CAD are not clear yet. Associations with extensive atherosclerosis, carotid lesions and complex coronary plaques in coronary CT scans were reported. Therefore, patients with elevated troponin levels represent a risk population and might profit from intensified secondary prevention. In this context, ticagrelor might be part of a prevention strategy as currently tested in the PEGASUS trial.
We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of our outpatient clinic, because data regarding prevalence, causes and prognosis of elevated troponin values in unselected cohorts is sparse. Therefore, all patients (n=910) that presented to our outpatient clinic 12 months after introduction of the high-sensitivity troponin T assay (june 2009) and were free of complaints or presented with UAP are being enrolled. All patients are characterized by demographic, laboratory and clinical characteristics (including medication) and all available imaging data (exercise-ecg, echocardiography, stress-echocardiography, computed tomography, cardiac MRI and coronary angiography) in order to compare baseline characteristics of troponin positive and troponin negative patients. In addition, the Framingham- and PROCAM-Score representing established calculators of long-term risk prediction are calculated.
Prognostic endpoints are defined as severe cardiovascular events and progress of the initially diagnosed disease. Those endpoints are associated with the initial hs-cTnT value and serial changes.
研究概览
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
We plan to conduct a single-centre pilot study in a cohort with clinically stable patients (n=910) of our outpatient clinic who presented 12 months after introduction of the high-sensitivity troponin T assay (june 2009) for routine workup. No patients will be excluded.
All patients with stable CAD with or without cardiovascular comorbidities will be selected and classified as "troponin positive" or "troponin negative" according to initially documented hs-cTnT value.
描述
Inclusion Criteria:
- Patients of outpatient clinic presenting 12 months after introduction of the hs-TnT test in june 2009
Exclusion Criteria:
- none
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Troponin status
Patients are divided into "troponin positive" (if hsTnT on first presentation is <14 ng/L) and "troponin negative" (if hsTnT on first presentation is >=14 ng/l).
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Progress of CHD
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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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心血管死亡
大体时间:3年
|
3年
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次要结果测量
结果测量 |
大体时间 |
---|---|
Recurrent Myocardial Infarction
大体时间:3 years
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3 years
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其他结果措施
结果测量 |
大体时间 |
---|---|
Recurrent coronary intervention
大体时间:3 years
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3 years
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合作者和调查者
出版物和有用的链接
一般刊物
- Biener M, Giannitsis E, Hogrefe K, Mueller-Hennessen M, Frohlich H, Katus HA, Frey N, Frankenstein L, Tager T. Prognostic value of changes in high-sensitivity cardiac troponin T beyond biological variation in stable outpatients with cardiovascular disease: a validation study. Clin Res Cardiol. 2022 Mar;111(3):333-342. doi: 10.1007/s00392-021-01952-6. Epub 2021 Oct 25.
- Tager T, Giannitsis E, Greve K, Frohlich H, Muller-Hennessen M, Vafaie M, Katus HA, Frankenstein L, Biener M. Long-term biological variation of high-sensitivity cardiac troponin T using minimal important differences and reference change values in stable outpatients with cardiovascular disease. Clin Biochem. 2019 May;67:7-11. doi: 10.1016/j.clinbiochem.2019.03.003. Epub 2019 Mar 11.
- Biener M, Giannitsis E, Kuhner M, Zelniker T, Mueller-Hennessen M, Vafaie M, Stoyanov KM, Neumann FJ, Katus HA, Hochholzer W, Valina CM. Risk prediction in stable cardiovascular disease using a high-sensitivity cardiac troponin T single biomarker strategy compared to the ESC-SCORE. Open Heart. 2018 Apr 25;5(1):e000710. doi: 10.1136/openhrt-2017-000710. eCollection 2018.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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University of Stellenbosch完全的
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