Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test in Elderly Patients (BOSCH2)
Comparison Between the New Highly Sensitive Troponin T and the Conventional Troponin T Test of the 4th Generation for the Early Identification of Myocardial Necrosis in Elderly Patients With Acute Coronary Syndromes Without ST-segment Elevation
研究概览
地位
条件
详细说明
All consecutive patients with acute symptoms and an age over 70 years will be recruited for the study during 6 months. Medical history, physical examination, vital signs including heart rate, blood pressure, body temperature, and any concomitant diseases are raised on admission in the Emergency Department. Blood samples are taken for determination of routine laboratory. Highly sensitive troponin T is determined as part of the routine. Troponin T is measured from the same blood sample with a conventional test of the 4th generation. A second blood sample is taken as part of routine 4-6 hours after the onset of symptoms to confirm or rule out any acute coronary syndrome. Patients are divided according to the interval between the onset of symptoms and presentation at the hospital in an "early"(<4 hours) and "late"(> = 4 hours) group.
The Barthel Index as a geriatric assessment is raised. An electrocardiogram is written in all patients at recording and evaluated. An echocardiographic examination is performed in all patients for measurement of heart valve function, left ventricular diameter, ejection fraction (LVEF) and diastolic function to differentiate into other mechanisms for the release of troponin. According to the results of the echocardiographic examination, patients are divided into sub-groups (LV-EF> = 55%) and without preserved ejection fraction (LVEF <55%). The recording physician estimates after receiving the results of the investigations and routine laboratory whether a myocardial infarction or heart failure is present. He subsequently makes the decision about further treatment. The medical records will be evaluated after completion of the stay in hospital by two experienced cardiologists, whether a heart attack, heart failure or other disease was present. High sensitivity Troponin T and Troponin T of the 4th generation are compared for the early and correct diagnosis of acute coronary syndrome.
Objectives:
- Incidence of acute coronary syndromes without ST-segment elevation in elderly patients by using the highly sensitive biomarker troponin T,
- Comparison with the incidence of acute coronary syndromes without ST-segment elevation in the same group by the use of troponin T of the 4th generation
- Survey on differential diagnoses such as heart failure or other cardiac diseases.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Nürnberg、德国、90419
- Klinikum
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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
描述
Inclusion Criteria:
- Age 70 or older
- Signed informed consent
Exclusion Criteria:
- Hospitalization for unstable angina pectoris within the last 2 month
- ST-segment elevation myocardial infarction
- Heart valve defects with need for surgical intervention
- Coronary bypass surgery or percutaneous transluminal angioplasty within the last 3 months
- Planned elective coronary revascularization
- Serum creatinine> 2.0 mg / dl (177 µmol / liter)
- Serum potassium> 5.5 mmol / l Limited survival probability within the next 3 months
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
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Time interval
Patients are divided according to the interval between the onset of chest pain symptoms and presentation at the hospital in an "early"(<4 hours) and "late"(> = 4 hours) group.
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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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Incidence of acute coronary syndromes without ST-segment elevation during hospitalization.
大体时间:30 days
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30 days
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次要结果测量
结果测量 |
大体时间 |
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Accurate diagnosis of myocardial infarction (without knowledge of biomarkers)
大体时间:30 days
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30 days
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Accurate diagnosis of acute heart failure (without knowledge of biomarkers)
大体时间:30 days
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30 days
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合作者和调查者
调查人员
- 首席研究员:Philipp Bahrmann, MD、Department of Internal Medicine II-2, Institute for Biomedicine of Ageing, Friedrich-Alexander-University Erlangen-Nürnberg
出版物和有用的链接
一般刊物
- Bahrmann P, Heppner HJ, Christ M, Bertsch T, Sieber C. Early detection of non-ST-elevation myocardial infarction in geriatric patients by a new high-sensitive cardiac troponin T assay. Aging Clin Exp Res. 2012 Jun;24(3):290-4. doi: 10.3275/7927. Epub 2011 Sep 26.
- Bahrmann P, Christ M, Bahrmann A, Rittger H, Heppner HJ, Achenbach S, Bertsch T, Sieber CC. A 3-hour diagnostic algorithm for non-ST-elevation myocardial infarction using high-sensitivity cardiac troponin T in unselected older patients presenting to the emergency department. J Am Med Dir Assoc. 2013 Jun;14(6):409-16. doi: 10.1016/j.jamda.2012.12.005. Epub 2013 Jan 30.
- Bahrmann P, Bahrmann A, Breithardt OA, Daniel WG, Christ M, Sieber CC, Bertsch T. Additional diagnostic and prognostic value of copeptin ultra-sensitive for diagnosis of non-ST-elevation myocardial infarction in older patients presenting to the emergency department. Clin Chem Lab Med. 2013 Jun;51(6):1307-19. doi: 10.1515/cclm-2012-0401.
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 (实际的)
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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