心肌肌钙蛋白诊断存在骨骼肌疾病的心肌梗死的可靠性 (H&M)
心脏与肌肉研究
Visits to the emergency department (ED) for chest pain are extremely common and require a safe, rapid and efficacious treatment algorithm to exclude a possible AMI. These diagnostic algorithms are partly based on an important laboratory value, which showed growing utility in the diagnostic and prognostic of many cardiovascular diseases in the last years : cardiac troponin.
However, some patients with muscle disease often present with unexplained elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in the absence of cardiac disease. The investigators aim at the characterization of the behaviour of this biomarker and its alternative (high-sensitive cardiac Troponin I), which will have important clinical implications on patients management.
研究概览
详细说明
Introduction: The detection of cardiomyocyte injury as quantified by blood concentrations of cardiac troponin T (cTnT) or I (cTnI) is central in the diagnosis of acute myocardial infarction (AMI). While multiple cardiac disorders other than AMI may also lead to cardiomyocyte injury and therefore elevations in cTnT and cTnI, latest generations of cTnT and cTnI assays are considered to have near exclusive cardiac-specificity. Overall, both analytes (cTnT and cTnI) seem to have comparable diagnostic accuracy among patients presenting with suspected AMI to the emergency department (ED). However, their use in the diagnosis of AMI in patients with a skeletal muscle disease is questioned, as especially cTnT was found to be elevated in this setting. These increased cTnT levels have been successively attributed to a possible re-expression of cTnT isoforms in the diseased muscle, to a primary cardiac involvement associated with the muscle disease or to a cross-reaction of the hs-cTnT assay with TnT of muscle origin.
Aim: To characterize cTn levels in patients with a skeletal muscle disease to assess their utility in the field of cardiology (through their implication in AMI diagnosis and their diagnostic and prognostic accuracy regarding a possible cardiac involvement) and in the field of neurology (for the detection and risk-stratification of the muscle disorder itself).
Methodology: This study will be conducted at the University Hospital of Basel, at the Kantonsspital Aarau, both in Switzerland, and at the University Hospital of Innsbruck, Austria. A prospective cohort patient will be recruited through the neurology, rheumatology and cardiology clinics of these three hospitals. This prospective cohort of patients presenting with skeletal muscle disease will allow us to systematically screen patients for cTn increases, to investigate the prevalence and characteristics of a possible primary cardiac involvement (as documented by electrocardiogram, echocardiography, magnetic resonance imaging, cTnI, NT-proBNP (N-terminal pro-B-type Natriuretic Peptide) and any available further cardiac testing) and to explore the origins of the elevated cTn levels using muscle biopsies. Furthermore, this prospective cohort will document the role of these biomarkers in the diagnosis, prognosis and risk-stratification of the muscle disease. Patients will receive a 1- and 3-year follow-up visit with blood draw in order to measure cTn and other biomarkers and record the impact of the evolution and treatment of the muscle disease on these levels. Major adverse cardiac events including cardiovascular death, AMI, hospitalization for heart failure, and the development of clinical or subclinical heart failure as quantified by elevated blood concentrations of NT-proBNP will be recorded during follow-up.
Potential significance: Elevated cTnT levels do not only have consequences regarding the diagnosis of AMI but also raise many questions regarding their possible use as a diagnostic, prognostic and risk-stratification marker regarding the different muscle injuries and their possible primary cardiac involvement.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Innsbruck
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Innsbruck、Innsbruck、奥地利、6020
- Medical University Innsbruck
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Bern、瑞士、3010
- Inselspital Bern
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Basel
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Basel、Basel、瑞士、4056
- University Hospital Basel
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Canton of Aargau
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Aarau、Canton of Aargau、瑞士、5001
- Canton Hospital of Aarau
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Canton of Zurich
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Zurich、Canton of Zurich、瑞士
- University Hospital Zürich
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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
Consecutive participants which have been or currently are in treatment for a muscle disease at the University hospital of Basel, at the Canton Hospital of Aarau, University Hospital of Zürich or Bern or at the Medical University of Innsbruck, or who received a new diagnosis/suspicion of such a disease will be included.
描述
Inclusion Criteria:
- Diagnostic or suspicion of muscle disease as presence of specified keyword in patient's file or as screened by colleagues of the rheumatology, neuromuscular or other medical clinics.
- Patient consent available
Exclusion Criteria:
- Patient's refusal
- Age <18 years old
- Terminal kidney insufficiency with need for dialysis.
- Temporary exclusion criteria : Acute health condition such as myocardial infarction, patients presenting with a major trauma, a sepsis, patients shortly after cardiac surgery, and patients in shock (>100 bpm, <90 systolic BP, evidence of organ dysfunction).
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
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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骨骼肌疾病患者通过不同的 hs-cTn 测定法测量的 cTnT 和 cTnI 水平的比较。
大体时间:1年
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1年
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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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在患有和不患有骨骼肌疾病的匹配患者中通过 hs 测定法测量的 cTnT 和 cTnI 水平的比较。
大体时间:1年
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1年
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在骨骼肌疾病与无骨骼肌疾病的背景下,不同患者特征对 hs-cTnI 和 hs-cTnT 水平的回归模型。
大体时间:1年
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1年
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Hs-cTn 水平在患有和不患有骨骼肌疾病的患者中的预后价值。
大体时间:3年
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3年
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CTnT 和 cTnI 在肌病患者骨骼肌活检中的特征。
大体时间:1年
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1年
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Characterization of the impact of cTnT and cTnI on the diagnosis and prognosis of muscle diseases
大体时间:3 years
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Prognosis defined as the incidence of Major Cardiovascular Events (MACE is defined as a composite of death, acute myocardial infarction, life-threatening arrhythmia (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV) -block III), cardiac arrest/reanimation, acute heart failure (requiring admission to a hospital or intra-hospital transfer to the intensive care unit), stroke/transient ischemic attack, pulmonary embolism) |
3 years
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其他结果措施
结果测量 |
大体时间 |
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新型 cTnT 检测方法的开发研究
大体时间:3年
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3年
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蛋白质表征
大体时间:3年
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3年
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心肌肌钙蛋白作为心脏受累的预测因子或筛查工具
大体时间:3年
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3年
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心肌肌钙蛋白作为肌肉疾病或肌肉再生的进化和治疗反应的预测因子。
大体时间:3年
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3年
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心肌肌钙蛋白在涉及肌肉的各种病因疾病中的特征
大体时间:3年
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3年
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肌肉症状对心肌肌钙蛋白的影响
大体时间:3年
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3年
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心肌肌钙蛋白与外周肌肉炎症/坏死的其他标志物(例如 CK)的对比。
大体时间:3年
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3年
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合作者和调查者
合作者
调查人员
- 首席研究员:Christian Mueller, MD、University Hospital, Basel, Switzerland
- 首席研究员:Angelika Hammerer, MD、Canton Hospital Aarau
- 首席研究员:Julia Wanschitz, MD、Medical University Innsbruck
出版物和有用的链接
一般刊物
- Schmid J, Liesinger L, Birner-Gruenberger R, Stojakovic T, Scharnagl H, Dieplinger B, Asslaber M, Radl R, Beer M, Polacin M, Mair J, Szolar D, Berghold A, Quasthoff S, Binder JS, Rainer PP. Elevated Cardiac Troponin T in Patients With Skeletal Myopathies. J Am Coll Cardiol. 2018 Apr 10;71(14):1540-1549. doi: 10.1016/j.jacc.2018.01.070.
- Jaffe AS, Vasile VC, Milone M, Saenger AK, Olson KN, Apple FS. Diseased skeletal muscle: a noncardiac source of increased circulating concentrations of cardiac troponin T. J Am Coll Cardiol. 2011 Oct 18;58(17):1819-24. doi: 10.1016/j.jacc.2011.08.026. Epub 2011 Sep 29.
- du Fay de Lavallaz J, Prepoudis A, Wendebourg MJ, Kesenheimer E, Kyburz D, Daikeler T, Haaf P, Wanschitz J, Loscher WN, Schreiner B, Katan M, Jung HH, Maurer B, Hammerer-Lercher A, Mayr A, Gualandro DM, Acket A, Puelacher C, Boeddinghaus J, Nestelberger T, Lopez-Ayala P, Glarner N, Shrestha S, Manka R, Gawinecka J, Piscuoglio S, Gallon J, Wiedemann S, Sinnreich M, Mueller C; BASEL XII Investigators. Skeletal Muscle Disorders: A Noncardiac Source of Cardiac Troponin T. Circulation. 2022 Jun 14;145(24):1764-1779. doi: 10.1161/CIRCULATIONAHA.121.058489. Epub 2022 Apr 7.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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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