休克试验:我们是否应该对闭塞的冠状动脉进行紧急血运重建以应对心源性休克。
研究概览
地位
地位
条件
条件
干预/治疗
干预/治疗
详细说明
背景:
在急诊室或院内诊断出的所有急性心肌梗死中,约有 7.5% 会导致心源性休克,院内死亡率为 70% 至 80%,通常在心源性休克诊断后一到两天内发生。 在过去的二十年里,高死亡率没有改变。 非随机临床系列和动物研究表明,在心源性休克并发急性心肌梗死后快速血运重建可能会大大提高生存率。 然而,非随机临床研究中报告的明显益处可能部分是由于对预后较好的患者的选择偏倚。
设计叙述:
随机、多中心、III 期、对照临床试验。 因左心室衰竭并发心肌梗死而休克的患者被随机分配到紧急血运重建组或初始药物稳定组。 血运重建通过冠状动脉旁路移植术或血管成形术完成。 共有 152 名患者被随机分配到早期血运重建组,150 名患者接受常规治疗,包括溶栓剂和可能的晚期血运重建尝试。 两组中 86% 的患者都进行了主动脉内球囊反搏。 主要终点是 30 天时全因死亡率。 次要终点包括六个月时的全因死亡率和对出院后幸存者生活质量的评估。
所有临床上疑似诊断为心源性休克并发心肌梗死的患者都形成了一个登记系统,收集了关于住院程序、药物、住院时间和出院时生命状况的有限信息。
该研究已延长至 2005 年 6 月,以进行患者随访和数据分析。 将估计长期存活率(MI 后 6 至 11 年),并研究急性 MI 并发心源性休克幸存者的生活质量。 将进行扩展试验数据分析:a) 确定与心源性休克患者一年生存相关的早期超声心动图参数,并评估这些参数与早期血运重建的相互作用; b) 检查病程和患者结果的差异作为年龄、性别、国家实践和系列血流动力学测量变化的函数,以及更好地描述心源性休克的相关病症和并发症。
研究类型
研究类型
阶段
阶段
- 第三阶段
参与标准
资格标准
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
描述
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
合作者和调查者
合作者
合作者
调查人员
调查人员
- Lynn Sleeper、New England Research Institute, Inc.
出版物和有用的链接
一般刊物
- Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.
- Ryan TJ. Early revascularization in cardiogenic shock--a positive view of a negative trial. N Engl J Med. 1999 Aug 26;341(9):687-8. doi: 10.1056/NEJM199908263410910. No abstract available.
- Menon V, Webb JG, Hillis LD, Sleeper LA, Abboud R, Dzavik V, Slater JN, Forman R, Monrad ES, Talley JD, Hochman JS. Outcome and profile of ventricular septal rupture with cardiogenic shock after myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1110-6. doi: 10.1016/s0735-1097(00)00878-0.
- Thompson CR, Buller CE, Sleeper LA, Antonelli TA, Webb JG, Jaber WA, Abel JG, Hochman JS. Cardiogenic shock due to acute severe mitral regurgitation complicating acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we use emergently revascularize Occluded Coronaries in cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1104-9. doi: 10.1016/s0735-1097(00)00846-9.
- Shindler DM, Palmeri ST, Antonelli TA, Sleeper LA, Boland J, Cocke TP, Hochman JS. Diabetes mellitus in cardiogenic shock complicating acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1097-103. doi: 10.1016/s0735-1097(00)00877-9.
- Jacobs AK, French JK, Col J, Sleeper LA, Slater JN, Carnendran L, Boland J, Jiang X, LeJemtel T, Hochman JS. Cardiogenic shock with non-ST-segment elevation myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1091-6. doi: 10.1016/s0735-1097(00)00888-3.
- Hochman JS, Sleeper LA, Godfrey E, McKinlay SM, Sanborn T, Col J, LeJemtel T. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK: an international randomized trial of emergency PTCA/CABG-trial design. The SHOCK Trial Study Group. Am Heart J. 1999 Feb;137(2):313-21. doi: 10.1053/hj.1999.v137.95352.
- Wong SC, Sanborn T, Sleeper LA, Webb JG, Pilchik R, Hart D, Mejnartowicz S, Antonelli TA, Lange R, French JK, Bergman G, LeJemtel T, Hochman JS. Angiographic findings and clinical correlates in patients with cardiogenic shock complicating acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1077-83. doi: 10.1016/s0735-1097(00)00873-1.
- Webb JG, Sleeper LA, Buller CE, Boland J, Palazzo A, Buller E, White HD, Hochman JS. Implications of the timing of onset of cardiogenic shock after acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1084-90. doi: 10.1016/s0735-1097(00)00876-7.
- Slater J, Brown RJ, Antonelli TA, Menon V, Boland J, Col J, Dzavik V, Greenberg M, Menegus M, Connery C, Hochman JS. Cardiogenic shock due to cardiac free-wall rupture or tamponade after acute myocardial infarction: a report from the SHOCK Trial Registry. Should we emergently revascularize occluded coronaries for cardiogenic shock? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1117-22. doi: 10.1016/s0735-1097(00)00845-7.
- Menon V, White H, LeJemtel T, Webb JG, Sleeper LA, Hochman JS. The clinical profile of patients with suspected cardiogenic shock due to predominant left ventricular failure: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1071-6. doi: 10.1016/s0735-1097(00)00874-3.
- Menon V, Slater JN, White HD, Sleeper LA, Cocke T, Hochman JS. Acute myocardial infarction complicated by systemic hypoperfusion without hypotension: report of the SHOCK trial registry. Am J Med. 2000 Apr 1;108(5):374-80. doi: 10.1016/s0002-9343(00)00310-7.
- Hochman JS, Buller CE, Sleeper LA, Boland J, Dzavik V, Sanborn TA, Godfrey E, White HD, Lim J, LeJemtel T. Cardiogenic shock complicating acute myocardial infarction--etiologies, management and outcome: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1063-70. doi: 10.1016/s0735-1097(00)00879-2.
- Sanborn TA, Sleeper LA, Bates ER, Jacobs AK, Boland J, French JK, Dens J, Dzavik V, Palmeri ST, Webb JG, Goldberger M, Hochman JS. Impact of thrombolysis, intra-aortic balloon pump counterpulsation, and their combination in cardiogenic shock complicating acute myocardial infarction: a report from the SHOCK Trial Registry. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? J Am Coll Cardiol. 2000 Sep;36(3 Suppl A):1123-9. doi: 10.1016/s0735-1097(00)00875-5.
- Hochman JS, Sleeper LA, White HD, Dzavik V, Wong SC, Menon V, Webb JG, Steingart R, Picard MH, Menegus MA, Boland J, Sanborn T, Buller CE, Modur S, Forman R, Desvigne-Nickens P, Jacobs AK, Slater JN, LeJemtel TH; SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. One-year survival following early revascularization for cardiogenic shock. JAMA. 2001 Jan 10;285(2):190-2. doi: 10.1001/jama.285.2.190.
- Webb JG, Sanborn TA, Sleeper LA, Carere RG, Buller CE, Slater JN, Baran KW, Koller PT, Talley JD, Porway M, Hochman JS; SHOCK Investigators. Percutaneous coronary intervention for cardiogenic shock in the SHOCK Trial Registry. Am Heart J. 2001 Jun;141(6):964-70. doi: 10.1067/mhj.2001.115294.
- Carnendran L, Abboud R, Sleeper LA, Gurunathan R, Webb JG, Menon V, Dzavik V, Cocke T, Hochman JS. Trends in cardiogenic shock: report from the SHOCK Study. The SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? Eur Heart J. 2001 Mar;22(6):472-8. doi: 10.1053/euhj.2000.2312.
- Wong SC, Sleeper LA, Monrad ES, Menegus MA, Palazzo A, Dzavik V, Jacobs A, Jiang X, Hochman JS; SHOCK Investigators. Absence of gender differences in clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction. A report from the SHOCK Trial Registry. J Am Coll Cardiol. 2001 Nov 1;38(5):1395-401. doi: 10.1016/s0735-1097(01)01581-9.
- Menon V, Fincke R. Cardiogenic shock: a summary of the randomized SHOCK trial. Congest Heart Fail. 2003 Jan-Feb;9(1):35-9. doi: 10.1111/j.1751-7133.2003.tb00020.x.
- Jacobs AK, Leopold JA, Bates E, Mendes LA, Sleeper LA, White H, Davidoff R, Boland J, Modur S, Forman R, Hochman JS. Cardiogenic shock caused by right ventricular infarction: a report from the SHOCK registry. J Am Coll Cardiol. 2003 Apr 16;41(8):1273-9. doi: 10.1016/s0735-1097(03)00120-7.
- Picard MH, Davidoff R, Sleeper LA, Mendes LA, Thompson CR, Dzavik V, Steingart R, Gin K, White HD, Hochman JS; SHOCK Trial. SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK. Echocardiographic predictors of survival and response to early revascularization in cardiogenic shock. Circulation. 2003 Jan 21;107(2):279-84. doi: 10.1161/01.cir.0000045667.11911.f6.
- Dzavik V, Sleeper LA, Cocke TP, Moscucci M, Saucedo J, Hosat S, Jiang X, Slater J, LeJemtel T, Hochman JS; SHOCK Investigators. Early revascularization is associated with improved survival in elderly patients with acute myocardial infarction complicated by cardiogenic shock: a report from the SHOCK Trial Registry. Eur Heart J. 2003 May;24(9):828-37. doi: 10.1016/s0195-668x(02)00844-8.
- Webb JG, Lowe AM, Sanborn TA, White HD, Sleeper LA, Carere RG, Buller CE, Wong SC, Boland J, Dzavik V, Porway M, Pate G, Bergman G, Hochman JS; SHOCK Investigators. Percutaneous coronary intervention for cardiogenic shock in the SHOCK trial. J Am Coll Cardiol. 2003 Oct 15;42(8):1380-6. doi: 10.1016/s0735-1097(03)01050-7.
- Sanborn TA, Sleeper LA, Webb JG, French JK, Bergman G, Parikh M, Wong SC, Boland J, Pfisterer M, Slater JN, Sharma S, Hochman JS; SHOCK Investigators. Correlates of one-year survival inpatients with cardiogenic shock complicating acute myocardial infarction: angiographic findings from the SHOCK trial. J Am Coll Cardiol. 2003 Oct 15;42(8):1373-9. doi: 10.1016/s0735-1097(03)01051-9.
- French JK, Feldman HA, Assmann SF, Sanborn T, Palmeri ST, Miller D, Boland J, Buller CE, Steingart R, Sleeper LA, Hochman JS; SHOCK Investigators. Influence of thrombolytic therapy, with or without intra-aortic balloon counterpulsation, on 12-month survival in the SHOCK trial. Am Heart J. 2003 Nov;146(5):804-10. doi: 10.1016/S0002-8703(03)00392-2.
- Fincke R, Hochman JS, Lowe AM, Menon V, Slater JN, Webb JG, LeJemtel TH, Cotter G; SHOCK Investigators. Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol. 2004 Jul 21;44(2):340-8. doi: 10.1016/j.jacc.2004.03.060.
- White HD, Palmeri ST, Sleeper LA, French JK, Wong CK, Lowe AM, Crapo JW, Koller PT, Baran KW, Boland JL, Hochman JS, Wagner GS; SHOCK Trial Investigators. Electrocardiographic findings in cardiogenic shock, risk prediction, and the effects of emergency revascularization: results from the SHOCK trial. Am Heart J. 2004 Nov;148(5):810-7. doi: 10.1016/j.ahj.2004.05.012.
- Sleeper LA, Ramanathan K, Picard MH, Lejemtel TH, White HD, Dzavik V, Tormey D, Avis NE, Hochman JS; SHOCK Investigators. Functional status and quality of life after emergency revascularization for cardiogenic shock complicating acute myocardial infarction. J Am Coll Cardiol. 2005 Jul 19;46(2):266-73. doi: 10.1016/j.jacc.2005.01.061.
- Kohsaka S, Menon V, Lowe AM, Lange M, Dzavik V, Sleeper LA, Hochman JS; SHOCK Investigators. Systemic inflammatory response syndrome after acute myocardial infarction complicated by cardiogenic shock. Arch Intern Med. 2005 Jul 25;165(14):1643-50. doi: 10.1001/archinte.165.14.1643.
- White HD, Assmann SF, Sanborn TA, Jacobs AK, Webb JG, Sleeper LA, Wong CK, Stewart JT, Aylward PE, Wong SC, Hochman JS. Comparison of percutaneous coronary intervention and coronary artery bypass grafting after acute myocardial infarction complicated by cardiogenic shock: results from the Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial. Circulation. 2005 Sep 27;112(13):1992-2001. doi: 10.1161/CIRCULATIONAHA.105.540948.
- Palmeri ST, Lowe AM, Sleeper LA, Saucedo JF, Desvigne-Nickens P, Hochman JS; SHOCK Investigators. Racial and ethnic differences in the treatment and outcome of cardiogenic shock following acute myocardial infarction. Am J Cardiol. 2005 Oct 15;96(8):1042-9. doi: 10.1016/j.amjcard.2005.06.033. Epub 2005 Aug 22.
- Dzavik V, Sleeper LA, Picard MH, Sanborn TA, Lowe AM, Gin K, Saucedo J, Webb JG, Menon V, Slater JN, Hochman JS; SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK Investigators. Outcome of patients aged >or=75 years in the SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK (SHOCK) trial: do elderly patients with acute myocardial infarction complicated by cardiogenic shock respond differently to emergent revascularization? Am Heart J. 2005 Jun;149(6):1128-34. doi: 10.1016/j.ahj.2005.03.045.
- Sleeper LA, Reynolds HR, White HD, Webb JG, Dzavik V, Hochman JS. A severity scoring system for risk assessment of patients with cardiogenic shock: a report from the SHOCK Trial and Registry. Am Heart J. 2010 Sep;160(3):443-50. doi: 10.1016/j.ahj.2010.06.024.
- Hochman JS, Sleeper LA, Webb JG, Dzavik V, Buller CE, Aylward P, Col J, White HD; SHOCK Investigators. Early revascularization and long-term survival in cardiogenic shock complicating acute myocardial infarction. JAMA. 2006 Jun 7;295(21):2511-5. doi: 10.1001/jama.295.21.2511.
研究记录日期
研究主要日期
学习开始
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (估计)
首次发布
研究记录更新
最后更新发布 (估计)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
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