在预测未分化胸痛患者的急性冠状动脉综合征时,连续心电图是否能辅助连续第二代肌钙蛋白? (ASAP Cath)
在预测未分化胸痛患者的急性冠状动脉综合征 (ASAP CATH) 研究中,连续心电图是否对连续第二代肌钙蛋白有帮助?
研究概览
详细说明
胸痛是急诊科 (ED) 评估的最常见症状之一。 评估本报告期间的主要诊断问题之一是是否存在急性冠脉综合征 (ACS) 的证据,因为 ACS 是短期和长期主要不良心血管事件(MACE,定义为急性心肌梗死)的主要危险因素、血运重建或全因死亡)。 该患者组基于指南的评估的两个基石是连续心电图 (ECG) 和肌钙蛋白测量(心肌缺血的血清学标志物),它们已被证明可以独立和递增地预测 ACS。 最近,第二代肌钙蛋白检测已被用于临床实践,因为与旧检测相比,它们对 ACS 具有更高的敏感性和特异性。 鉴于这些新型第二代检测方法提高了诊断准确性,拟议研究的研究问题是调查连续 ECG 变化是否显着提高连续第二代肌钙蛋白变化在预测症状与 ACS 一致的患者的 MACE 方面的诊断准确性。 为了调查这个问题,我们最初提出了一项辅助 HEART 通路试验 (WFUHS IRB00021074) 的观察性试点研究,这是一项受资助的随机对照试验,调查最近开发的决策辅助工具(HEART 评分),旨在识别接受胸部评估的患者可以安全地放弃进一步客观测试的痛苦。 我们建议在 HEART Pathway 试验的方案中增加两个额外的 12 导联心电图的收集,其中包括系列第二代肌钙蛋白收集,以生成有关研究问题的试验数据。 由于 HEART 通路试验的招募已于 2014 年 2 月结束,我们现在建议继续独立招募 ASAP CATH 研究,作为一项前瞻性观察研究,评估连续心电图对标准治疗对评估急性胸痛患者的额外预后价值急诊科的冠状动脉综合征。
客观的:
该项目的目标是产生初步数据,以调查是否存在提示心肌缺血的连续 ECG 变化是否有助于重新分类参与者的 MACE 风险和 ACS 的客观证据,而不是连续的第二代肌钙蛋白测试。
方法:
21 岁以上的成年患者因胸痛或与 ACS 有关的症状就诊于 WFBMC ED,其中提供者订购心脏生物标志物和 ECG 将有资格入组。 我们的目标是将系列心电图分析(一次在研究登记时,第二次在研究抽血时)添加到拟议研究的方案中。 主要结局是 30 天时的主要不良心血管事件 (MACE) 和通过住院期间进行的客观心脏测试获得的急性心肌缺血证据。
研究类型
注册 (预期的)
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Baptist Medical Center - Emergency Department
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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
纳入标准:
- 入学时年龄大于或等于 21 岁
- 在获得用于患者评估的心电图和心脏生物标志物后,治疗医师指出的胸部不适或其他与可能的 ACS 一致的症状
- 治疗医师认为如果排除心脏病,患者可以出院回家
排除标准:
- 初始心电图 ST 段抬高型心肌梗死 (STEMI) 或左束支传导阻滞 (LBBB) 的证据
- 左心室收缩功能障碍(左心室射血分数<40%的病史或充血性心力衰竭的活动症状)
- 初始心电图出现新的或不受控制的室性心律失常
- 血液动力学不稳定:心率 > 120 bpm 或 < 40 bpm 和/或收缩压 <100 mmHg
- 低氧血症(室内空气或正常家庭氧气流速下的氧饱和度 <90%)
- 预期寿命不足1年的终末诊断
- 由提供者确定需要入院、增加客观心脏测试风险或阻止在阴性测试后立即出院的非心脏内科、外科或精神疾病。
- 事先注册
- 无能力或不愿同意并遵守研究程序
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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串行心电图臂
所有研究参与者都将收到系列心电图。
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所有参与者都将进行系列心电图检查。
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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 |
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30 天时的主要不良心血管事件
大体时间:30天
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确定系列心电图变化是否显着提高系列第二代肌钙蛋白测量在预测 30 天时有症状提示 ACS 患者的 MACE 时的诊断准确性。
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30天
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通过在指数住院期间进行的客观心脏测试获得急性心肌缺血的证据
大体时间:首次住院时间,通常为 1 至 2 天
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确定系列 ECG 变化是否显着提高系列第二代肌钙蛋白测量的诊断准确性,以预测正接受 ACS 评估的患者的心脏负荷测试阳性或冠状动脉造影结果指示急性心肌缺血。
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首次住院时间,通常为 1 至 2 天
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30 天时的主要不良心血管事件
大体时间:30天
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确定连续 ECG 变化是否显着提高连续第二代肌钙蛋白测量的诊断准确性,以预测具有提示 ACS 症状的患者 30 天时的主要不良心血管事件。
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30天
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合作者和调查者
出版物和有用的链接
一般刊物
- Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction; Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernandez-Aviles F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. doi: 10.1161/CIRCULATIONAHA.107.187397. Epub 2007 Oct 19. No abstract available.
- Keller T, Zeller T, Peetz D, Tzikas S, Roth A, Czyz E, Bickel C, Baldus S, Warnholtz A, Frohlich M, Sinning CR, Eleftheriadis MS, Wild PS, Schnabel RB, Lubos E, Jachmann N, Genth-Zotz S, Post F, Nicaud V, Tiret L, Lackner KJ, Munzel TF, Blankenberg S. Sensitive troponin I assay in early diagnosis of acute myocardial infarction. N Engl J Med. 2009 Aug 27;361(9):868-77. doi: 10.1056/NEJMoa0903515.
- Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr; 2011 WRITING GROUP MEMBERS; ACCF/AHA TASK FORCE MEMBERS. 2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 May 10;123(18):e426-579. doi: 10.1161/CIR.0b013e318212bb8b. Epub 2011 Mar 28. No abstract available. Erratum In: Circulation. 2011 Jun 7;123(22):e627.
- Owens PL, Barrett ML, Gibson TB, Andrews RM, Weinick RM, Mutter RL. Emergency department care in the United States: a profile of national data sources. Ann Emerg Med. 2010 Aug;56(2):150-65. doi: 10.1016/j.annemergmed.2009.11.022. Epub 2010 Jan 15.
- Mahler SA, Hiestand BC, Goff DC Jr, Hoekstra JW, Miller CD. Can the HEART score safely reduce stress testing and cardiac imaging in patients at low risk for major adverse cardiac events? Crit Pathw Cardiol. 2011 Sep;10(3):128-33. doi: 10.1097/HPC.0b013e3182315a85.
- Hedges JR, Young GP, Henkel GF, Gibler WB, Green TR, Swanson JR. Serial ECGs are less accurate than serial CK-MB results for emergency department diagnosis of myocardial infarction. Ann Emerg Med. 1992 Dec;21(12):1445-50. doi: 10.1016/s0196-0644(05)80057-5.
- Fesmire FM, Percy RF, Bardoner JB, Wharton DR, Calhoun FB. Usefulness of automated serial 12-lead ECG monitoring during the initial emergency department evaluation of patients with chest pain. Ann Emerg Med. 1998 Jan;31(1):3-11. doi: 10.1016/s0196-0644(98)70274-4.
- Carmo P, Ferreira J, Aguiar C, Ferreira A, Raposo L, Goncalves P, Brito J, Silva A. Does continuous ST-segment monitoring add prognostic information to the TIMI, PURSUIT, and GRACE risk scores? Ann Noninvasive Electrocardiol. 2011 Jul;16(3):239-49. doi: 10.1111/j.1542-474X.2011.00438.x.
- Yan AT, Yan RT, Tan M, Senaratne M, Fitchett DH, Langer A, Goodman SG; INTERACT Investigators. Long-term prognostic value and therapeutic implications of continuous ST-segment monitoring in acute coronary syndrome. Am Heart J. 2007 Apr;153(4):500-6. doi: 10.1016/j.ahj.2007.02.003.
- Jernberg T, Lindahl B, Wallentin L. The combination of a continuous 12-lead ECG and troponin T; a valuable tool for risk stratification during the first 6 hours in patients with chest pain and a non-diagnostic ECG. Eur Heart J. 2000 Sep;21(17):1464-72. doi: 10.1053/euhj.2000.2178.
- Norgaard BL, Andersen K, Dellborg M, Abrahamsson P, Ravkilde J, Thygesen K. Admission risk assessment by cardiac troponin T in unstable coronary artery disease: additional prognostic information from continuous ST segment monitoring. TRIM study group. Thrombin Inhibition in Myocardial Ischemia. J Am Coll Cardiol. 1999 May;33(6):1519-27. doi: 10.1016/s0735-1097(99)00080-7.
- Fesmire FM, Decker WW, Diercks DB, Ghaemmaghami CA, Nazarian D, Brady WJ, Hahn S, Jagoda AS; American College of Emergency Physicians Clinical Policies Subcommittee (Writing Committee) on Non-ST-Segment Elevation Acute Coronary Syndromes. Clinical policy: critical issues in the evaluation and management of adult patients with non-ST-segment elevation acute coronary syndromes. Ann Emerg Med. 2006 Sep;48(3):270-301. doi: 10.1016/j.annemergmed.2006.07.005. No abstract available.
- Antman EM, Tanasijevic MJ, Thompson B, Schactman M, McCabe CH, Cannon CP, Fischer GA, Fung AY, Thompson C, Wybenga D, Braunwald E. Cardiac-specific troponin I levels to predict the risk of mortality in patients with acute coronary syndromes. N Engl J Med. 1996 Oct 31;335(18):1342-9. doi: 10.1056/NEJM199610313351802.
- Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. doi: 10.1016/s0735-1097(00)00804-4. Erratum In: J Am Coll Cardiol 2001 Mar 1;37(3):973.
- Luepker RV, Apple FS, Christenson RH, Crow RS, Fortmann SP, Goff D, Goldberg RJ, Hand MM, Jaffe AS, Julian DG, Levy D, Manolio T, Mendis S, Mensah G, Pajak A, Prineas RJ, Reddy KS, Roger VL, Rosamond WD, Shahar E, Sharrett AR, Sorlie P, Tunstall-Pedoe H; AHA Council on Epidemiology and Prevention; AHA Statistics Committee; World Heart Federation Council on Epidemiology and Prevention; European Society of Cardiology Working Group on Epidemiology and Prevention; Centers for Disease Control and Prevention; National Heart, Lung, and Blood Institute. Case definitions for acute coronary heart disease in epidemiology and clinical research studies: a statement from the AHA Council on Epidemiology and Prevention; AHA Statistics Committee; World Heart Federation Council on Epidemiology and Prevention; the European Society of Cardiology Working Group on Epidemiology and Prevention; Centers for Disease Control and Prevention; and the National Heart, Lung, and Blood Institute. Circulation. 2003 Nov 18;108(20):2543-9. doi: 10.1161/01.CIR.0000100560.46946.EA. Epub 2003 Nov 10. No abstract available.
- Norgaard BL, Andersen K, Thygesen K, Ravkilde J, Abrahamsson P, Grip L, Dellborg M. Long term risk stratification of patients with acute coronary syndromes: characteristics of troponin T testing and continuous ST segment monitoring. Heart. 2004 Jul;90(7):739-44. doi: 10.1136/hrt.2003.020479.
- Katus HA, Remppis A, Neumann FJ, Scheffold T, Diederich KW, Vinar G, Noe A, Matern G, Kuebler W. Diagnostic efficiency of troponin T measurements in acute myocardial infarction. Circulation. 1991 Mar;83(3):902-12. doi: 10.1161/01.cir.83.3.902.
- Melanson SE, Morrow DA, Jarolim P. Earlier detection of myocardial injury in a preliminary evaluation using a new troponin I assay with improved sensitivity. Am J Clin Pathol. 2007 Aug;128(2):282-6. doi: 10.1309/Q9W5HJTT24GQCXXX.
- Aldous SJ, Richards M, Cullen L, Troughton R, Than M. Diagnostic and prognostic utility of early measurement with high-sensitivity troponin T assay in patients presenting with chest pain. CMAJ. 2012 Mar 20;184(5):E260-8. doi: 10.1503/cmaj.110773. Epub 2012 Jan 30.
- Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American College of Radiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; American Society of Nuclear Cardiology; North American Society for Cardiac Imaging; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006 Oct 3;48(7):1475-97. doi: 10.1016/j.jacc.2006.07.003. No abstract available.
- Hollander JE, Blomkalns AL, Brogan GX, Diercks DB, Field JM, Garvey JL, Gibler WB, Henry TD, Hoekstra JW, Holroyd BR, Hong Y, Kirk JD, O'Neil BJ, Jackson RE; Multidisciplinary Standardized Reporting Criteria Task Force. Standardized reporting guidelines for studies evaluating risk stratification of ED patients with potential acute coronary syndromes. Acad Emerg Med. 2004 Dec;11(12):1331-40. doi: 10.1197/j.aem.2004.08.033. No abstract available.
- Bonaca M, Scirica B, Sabatine M, Dalby A, Spinar J, Murphy SA, Jarolim P, Braunwald E, Morrow DA. Prospective evaluation of the prognostic implications of improved assay performance with a sensitive assay for cardiac troponin I. J Am Coll Cardiol. 2010 May 11;55(19):2118-24. doi: 10.1016/j.jacc.2010.01.044.
- Ronald J. Prineas RSC, Zhu-Ming Zhang. The minnesota code manual of electrocardiographic findings. London: Springer-Verlag; 2010.
- Rautaharju PM, MacInnis PJ, Warren JW, Wolf HK, Rykers PM, Calhoun HP. Methodology of ECG interpretation in the Dalhousie program; NOVACODE ECG classification procedures for clinical trials and population health surveys. Methods Inf Med. 1990 Sep;29(4):362-74.
- Miller CD, Hoekstra JW, Lefebvre C, Blumstein H, Hamilton CA, Harper EN, Mahler S, Diercks DB, Neiberg R, Hundley WG. Provider-directed imaging stress testing reduces health care expenditures in lower-risk chest pain patients presenting to the emergency department. Circ Cardiovasc Imaging. 2012 Jan;5(1):111-8. doi: 10.1161/CIRCIMAGING.111.965293. Epub 2011 Nov 29.
- Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305.
研究记录日期
研究主要日期
学习开始 (实际的)
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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