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Short- and Long-Term Risk Stratification Using a Next-Generation, High-Sensitivity Research Cardiac Troponin I (hs-cTnI) Assay in an Emergency Department Chest Pain Population

机译:在急诊科胸痛人群中使用新一代高灵敏度研究性心肌钙蛋白I(hs-cTnI)测定的短期和长期风险分层

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The next-generation, high-sensitivity cardiac troponin assays can measure quantifiable concentrations of cTn in a majority of individuals, but there are few studies assessing these assays for risk stratification. The present study was undertaken to determine if a research hs-cTnI assay can be useful for predicting death/myocardial infarction (MI), both short- and long-term, in an emergency department acute coronary syndrome (ACS) population. In a cohort of 383 subjects, originally recruited in 1996, presenting to the emergency department with symptoms suggestive of ACS, the heparin plasma obtained at initial presentation was thawed and measured in 2007 with a research hs-cTnI assay. AccuTnI (Beckman Coulter) measurements were made on these same samples in 2003. The population was divided into 4 groups by hs-cTnI: 40.00 ng/L. Kaplan-Meier, Cox proportional hazards, ROC curves, and logistic regression analyses were used to identify which hs-cTnI concentrations were predictive of death/MI within 10 years after presentation. There were significant differences between the hs-cTnI groups for the probability of death/MI up to 10 years after presentation (P 3.7; P < 0.05) compared with those having hs-cTnI <5.00 ng/L. ROC curve analysis for death/MI at 30 days with the hs-cTnI assay had an area under the curve of 0.74 (95% CI 0.65-0.82), with logistic models yielding an optimal assay threshold of 12.68 ng/L. This research hs-cTnI assay appears useful for risk stratification for death/MI in an ACS population.
机译:下一代,高灵敏度的心肌肌钙蛋白测定法可以测量大多数个体中cTn的定量浓度,但是很少有研究评估这些测定法的风险分层。进行本研究是为了确定研究性hs-cTnI分析是否可用于预测急诊科急性冠脉综合征(ACS)人群的短期和长期死亡/心肌梗塞(MI)。在最初于1996年招募的383名受试者中,他们向急诊科呈示ACS症状,在2007年用研究hs-cTnI分析法对初次获得的肝素血浆进行了解冻和测量。 2003年对这些相同样品进行了AccuTnI(贝克曼库尔特)测量。hs-cTnI:40.00 ng / L将种群分为4组。使用Kaplan-Meier,Cox比例风险,ROC曲线和logistic回归分析来确定在陈述后10年内哪些hs-cTnI浓度可预测死亡/ MI。与出现hs-cTnI <5.00 ng / L的患者相比,出现hs-cTnI的人群在出现后10年内死亡/心梗的可能性存在显着差异(P 3.7; P <0.05)。使用hs-cTnI分析在30天时对死亡/心肌梗死的ROC曲线分析的曲线下面积为0.74(95%CI 0.65-0.82),逻辑模型得出的最佳分析阈值为12.68 ng / L。这项研究hs-cTnI分析对于ACS人群死亡/ MI的危险分层很有用。

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    《Clinical Chemistry》 |2009年第10期|p.1809-1815|共7页
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    Peter A. Kavsak,1* Xuesong Wang,2 Dennis T. Ko,2 Andrew R. MacRae,3 and Allan S. Jaffe41 Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada, 2 Institute for Clinical Evaluative Sciences, University of Toronto, ON, Canada, 3 Department of Biochemistry and Medical Genetics, University of Manitoba, Winnipeg, MB, Canada, and 4 Cardiovascular Division and Division of Laboratory Medicine, Mayo Clinic, Rochester, MN.* Address correspondence to this author at: Hamilton Regional Laboratory Medicine Program, Henderson General Hospital (Core Lab Section), 711 Concession St., Hamilton, ON, Canada. Fax 905-575-2581, e-mail kavsakp@mcmaster.ca.Received March 12, 2009, accepted July 15, 2009.Previously published online at DOI: 10.1373/clinchem.2009.127241Author Contributions: All authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data, (b) drafting or revising the article for intellectual content, and (c) final approval of the published article.Authors' Disclosures of Potential Conflicts of Interest: Upon manuscript submission, all authors completed the Disclosures of Potential Conflict of Interest form. Potential conflicts of interest:Employment or Leadership: None declared.Consultant or Advisory Role: A.R. MacRae, Beckman Coulter, A.S. Jaffe, Siemens, Beckman Coulter, Ortho Diagnostics, Singulex, Nanosphere, Inverness, Critical Diagnostics, GlaxoSmithKline, and Novartis.Stock Ownership: None declared.Honoraria: P.A. Kavsak, Beckman Coulter.Research Funding: Canadian Institutes of Health Research. P.A. Kavsak, Beckman Coulter. A.S. Jaffe, Siemens and Beckman Coulter. Reagents were provided as an unrestricted grant by Beckman Coulter.Expert Testimony: None declared.Role of Sponsor: The funding organizations played no role in the design of study, choice of enrolled patients, review and interpretation of data, or preparation or approval of manuscript.Acknowledgments: Special thanks to the Clinical Research and Clinical Trials Laboratory, Hamilton, for performing the laboratory measurements.,;

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