急性心肌梗死试验后的活性引导血管成形术（VIAMI 试验）
2008年9月4日 更新者：Netherlands Heart Foundation
急性心肌梗死后早期梗死区存活患者梗死相关动脉选择性支架置入术的早期和长期结果。 VIAMI-试验。
VIAMI 试验研究了在急性心肌梗塞后的早期阶段，球囊血管成形术和梗塞血管支架置入术的效果。
该研究涉及在接受溶栓治疗后梗塞区域仍有残留活组织的患者。
据推测，只有具有剩余活组织的患者才处于复发性梗塞或心绞痛发作的高风险中，并且梗塞血管的支架植入术将大大降低这种风险。
研究概览
详细说明
早期的研究表明，在急性心肌梗死溶栓后立即对梗死相关冠状动脉进行常规血管成形术并没有带来临床益处。 这一发现强调了选择近期心肌梗死患者亚组的重要性，他们将真正受益于梗死相关动脉的血管成形术。
几项研究表明，急性心肌梗死后早期梗死区存在活力会增加新的心脏事件的风险，如复发性梗死、心绞痛和需要冠状动脉介入治疗。 因此，据推测只有在梗塞区域具有生存能力的患者才会在急性心肌梗塞后早期从血管成形术中获益。
在 VIAMI 试验中，因急性心肌梗死入院且未立即进行冠状动脉血管成形术的患者将在入院后 3 天内通过多巴酚丁胺超声心动图进行活力测试。 在梗塞区域具有明确生存迹象的患者将被随机分配到侵入性或保守治疗策略中。 在侵入性策略中，患者将接受冠状动脉造影术，目的是对梗死相关的冠状动脉进行球囊血管成形术和支架术，同时使用静脉内血小板抑制剂阿昔单抗。 在保守组中，只有当出现新的即将发生的梗死或复发性缺血时，患者才会接受冠状动脉造影和血管成形术。 在侵入性组中，球囊血管成形术将在随机化后尽快进行。 没有生存能力的患者将不会被随机分配，但将作为对照组参加。
研究类型
介入性
注册
300
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alkmaar、荷兰、1815 JD
- Medical Center Alkmaar (MCA)
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Amsterdam、荷兰、1058 NR
- Sint LucasAndreas Hospital
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Amsterdam、荷兰、1081 HV
- VU University Medical Center
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Eindhoven、荷兰、5623 EJ
- Catharina Hospital
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Haarlem、荷兰、2000 AK
- Kennemer Gasthuis
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Heerlen、荷兰、6401 CX
- Atrium medical center Heerlen
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Hilversum、荷兰、1213 XZ
- Hospital Hilversum
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Leiderdorp、荷兰、2350 CC
- Rijnland Hospital
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Nijmegen、荷兰、6525 GA
- University Medical Center St. Radboud
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Purmerend、荷兰、1441 RN
- Waterland Hospital
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Utrecht、荷兰、3582 KE
- Diakonessenhuis
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Zaandam、荷兰、1500 EE
- Zaans Medical Center "De Heel"
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 疼痛发作后 6 小时内入院且 EKG 两个或多个标准导联 ST 段抬高≥ 1 mm 或两个相邻胸导联 ST 段抬高 ≥ 2 mm，表明透壁缺血，伴有或不伴有新的 Q-波，通过酶升高证明心肌坏死（总 CPK ≥ 正常上限的 2 倍）。
- 患者病史符合亚急性心肌梗死（≥ 6 小时），心电图上至少有心肌坏死迹象（Q 波）和心脏特异性酶的血清水平显着升高。
- 年龄在 18 至 80 岁之间。
- 冠状动脉造影前进行的生存力测试。
- 在生存力测试之前没有进行侵入性操作的临床指征
排除标准：
- 未获得知情同意
- 不可靠的跟进
- 可行性测试在技术上是不可能的
- 多巴酚丁胺超声心动图的禁忌症（心力衰竭、心律失常）
- 冠状动脉造影的禁忌症，如严重的糖尿病肾病或已知造影剂过敏
- 已知对阿昔单抗过敏
- 严重的、危及生命的非心脏疾病
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
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死亡
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复发性心肌梗死
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需要住院治疗的不稳定型心绞痛
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30 天、6 个月和 1 年的分析
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次要结果测量
结果测量 |
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左心室功能（超声心动图）
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心力衰竭发病率 (NYHA)
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心绞痛类（CCS）
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需要血运重建程序
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3 个月和 6 个月以及 1 年后的分析
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Gerrit Veen, MD, PhD、VU University medical center, Amsterdam, The Netherlands
- 学习椅：Cees A Visser, MD, PhD、VU University medical center, Amsterdam, The Netherlands
- 研究主任：Frans C Visser, MD, PhD、Amsterdam UMC, location VUMc
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Ornato JP. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004 Aug 4;44(3):E1-E211. doi: 10.1016/j.jacc.2004.07.014. No abstract available.
- Van de Werf F, Ardissino D, Betriu A, Cokkinos DV, Falk E, Fox KA, Julian D, Lengyel M, Neumann FJ, Ruzyllo W, Thygesen C, Underwood SR, Vahanian A, Verheugt FW, Wijns W; Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2003 Jan;24(1):28-66. doi: 10.1016/s0195-668x(02)00618-8. No abstract available.
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- Morrow DA, Antman EM, Parsons L, de Lemos JA, Cannon CP, Giugliano RP, McCabe CH, Barron HV, Braunwald E. Application of the TIMI risk score for ST-elevation MI in the National Registry of Myocardial Infarction 3. JAMA. 2001 Sep 19;286(11):1356-9. doi: 10.1001/jama.286.11.1356.
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- ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. Lancet. 1992 Mar 28;339(8796):753-70.
- GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med. 1993 Nov 25;329(22):1615-22. doi: 10.1056/NEJM199311253292204. Erratum In: N Engl J Med 1994 Feb 17;330(7):516.
- Meijer A, Verheugt FW, Werter CJ, Lie KI, van der Pol JM, van Eenige MJ. Aspirin versus coumadin in the prevention of reocclusion and recurrent ischemia after successful thrombolysis: a prospective placebo-controlled angiographic study. Results of the APRICOT Study. Circulation. 1993 May;87(5):1524-30. doi: 10.1161/01.cir.87.5.1524.
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- Meijer A, Verheugt FW, van Eenige MJ, Werter CJ. Left ventricular function at 3 months after successful thrombolysis. Impact of reocclusion without reinfarction on ejection fraction, regional function, and remodeling. Circulation. 1994 Oct;90(4):1706-14. doi: 10.1161/01.cir.90.4.1706.
- Nijland F, Kamp O, Verheugt FW, Veen G, Visser CA. Long-term implications of reocclusion on left ventricular size and function after successful thrombolysis for first anterior myocardial infarction. Circulation. 1997 Jan 7;95(1):111-7. doi: 10.1161/01.cir.95.1.111.
- TIMI Study Group. Comparison of invasive and conservative strategies after treatment with intravenous tissue plasminogen activator in acute myocardial infarction. Results of the thrombolysis in myocardial infarction (TIMI) phase II trial. N Engl J Med. 1989 Mar 9;320(10):618-27. doi: 10.1056/NEJM198903093201002.
- SWIFT trial of delayed elective intervention v conservative treatment after thrombolysis with anistreplase in acute myocardial infarction. SWIFT (Should We Intervene Following Thrombolysis?) Trial Study Group. BMJ. 1991 Mar 9;302(6776):555-60. doi: 10.1136/bmj.302.6776.555.
- Erbel R, Pop T, Henrichs KJ, von Olshausen K, Schuster CJ, Rupprecht HJ, Steuernagel C, Meyer J. Percutaneous transluminal coronary angioplasty after thrombolytic therapy: a prospective controlled randomized trial. J Am Coll Cardiol. 1986 Sep;8(3):485-95. doi: 10.1016/s0735-1097(86)80172-3.
- Guerci AD, Gerstenblith G, Brinker JA, Chandra NC, Gottlieb SO, Bahr RD, Weiss JL, Shapiro EP, Flaherty JT, Bush DE, et al. A randomized trial of intravenous tissue plasminogen activator for acute myocardial infarction with subsequent randomization to elective coronary angioplasty. N Engl J Med. 1987 Dec 24;317(26):1613-8. doi: 10.1056/NEJM198712243172601.
- Rogers WJ, Baim DS, Gore JM, Brown BG, Roberts R, Williams DO, Chesebro JH, Babb JD, Sheehan FH, Wackers FJ, et al. Comparison of immediate invasive, delayed invasive, and conservative strategies after tissue-type plasminogen activator. Results of the Thrombolysis in Myocardial Infarction (TIMI) Phase II-A trial. Circulation. 1990 May;81(5):1457-76. doi: 10.1161/01.cir.81.5.1457.
- Simoons ML, Arnold AE, Betriu A, de Bono DP, Col J, Dougherty FC, von Essen R, Lambertz H, Lubsen J, Meier B, et al. Thrombolysis with tissue plasminogen activator in acute myocardial infarction: no additional benefit from immediate percutaneous coronary angioplasty. Lancet. 1988 Jan 30;1(8579):197-203. doi: 10.1016/s0140-6736(88)91062-8.
- Topol EJ, Califf RM, George BS, Kereiakes DJ, Abbottsmith CW, Candela RJ, Lee KL, Pitt B, Stack RS, O'Neill WW. A randomized trial of immediate versus delayed elective angioplasty after intravenous tissue plasminogen activator in acute myocardial infarction. N Engl J Med. 1987 Sep 3;317(10):581-8. doi: 10.1056/NEJM198709033171001.
- Froelicher VF, Perdue S, Pewen W, Risch M. Application of meta-analysis using an electronic spread sheet to exercise testing in patients after myocardial infarction. Am J Med. 1987 Dec;83(6):1045-54. doi: 10.1016/0002-9343(87)90940-5.
- Basu S, Senior R, Raval U, Lahiri A. Superiority of nitrate-enhanced 201Tl over conventional redistribution 201Tl imaging for prognostic evaluation after myocardial infarction and thrombolysis. Circulation. 1997 Nov 4;96(9):2932-7. doi: 10.1161/01.cir.96.9.2932.
- Bigi R, Desideri A, Bax JJ, Galati A, Coletta C, Fiorentini C, Fioretti PM. Prognostic interaction between viability and residual myocardial ischemia by dobutamine stress echocardiography in patients with acute myocardial infarction and mildly impaired left ventricular function. Am J Cardiol. 2001 Feb 1;87(3):283-8. doi: 10.1016/s0002-9149(00)01359-x.
- Huitink JM, Visser FC, Bax JJ, van Lingen A, Groenveld AB, Teule GJ, Visser CA. Predictive value of planar 18F-fluorodeoxyglucose imaging for cardiac events in patients after acute myocardial infarction. Am J Cardiol. 1998 May 1;81(9):1072-7. doi: 10.1016/s0002-9149(98)00143-x.
- Lee KS, Marwick TH, Cook SA, Go RT, Fix JS, James KB, Sapp SK, MacIntyre WJ, Thomas JD. Prognosis of patients with left ventricular dysfunction, with and without viable myocardium after myocardial infarction. Relative efficacy of medical therapy and revascularization. Circulation. 1994 Dec;90(6):2687-94. doi: 10.1161/01.cir.90.6.2687.
- Tieleman RG, Van Gelder IC, Crijns HJ, De Kam PJ, Van Den Berg MP, Haaksma J, Van Der Woude HJ, Allessie MA. Early recurrences of atrial fibrillation after electrical cardioversion: a result of fibrillation-induced electrical remodeling of the atria? J Am Coll Cardiol. 1998 Jan;31(1):167-73. doi: 10.1016/s0735-1097(97)00455-5.
- Nijland F, Kamp O, Verhorst PM, de Voogt WG, Visser CA. In-hospital and long-term prognostic value of viable myocardium detected by dobutamine echocardiography early after acute myocardial infarction and its relation to indicators of left ventricular systolic dysfunction. Am J Cardiol. 2001 Nov 1;88(9):949-55. doi: 10.1016/s0002-9149(01)01968-3.
- Petretta M, Cuocolo A, Bonaduce D, Nicolai E, Cardei S, Berardino S, Ianniciello A, Apicella C, Bianchi V, Salvatore M. Incremental prognostic value of thallium reinjection after stress-redistribution imaging in patients with previous myocardial infarction and left ventricular dysfunction. J Nucl Med. 1997 Feb;38(2):195-200.
- Previtali M, Fetiveau R, Lanzarini L, Cavalotti C, Klersy C. Prognostic value of myocardial viability and ischemia detected by dobutamine stress echocardiography early after acute myocardial infarction treated with thrombolysis. J Am Coll Cardiol. 1998 Aug;32(2):380-6. doi: 10.1016/s0735-1097(98)00243-5.
- Salustri A, Ciavatti M, Seccareccia F, Palamara A. Prediction of cardiac events after uncomplicated acute myocardial infarction by clinical variables and dobutamine stress test. J Am Coll Cardiol. 1999 Aug;34(2):435-40. doi: 10.1016/s0735-1097(99)00232-6.
- Sicari R, Picano E, Landi P, Pingitore A, Bigi R, Coletta C, Heyman J, Casazza F, Previtali M, Mathias W Jr, Dodi C, Minardi G, Lowenstein J, Garyfallidis X, Cortigiani L, Morales MA, Raciti M. Prognostic value of dobutamine-atropine stress echocardiography early after acute myocardial infarction. Echo Dobutamine International Cooperative (EDIC) Study. J Am Coll Cardiol. 1997 Feb;29(2):254-60. doi: 10.1016/s0735-1097(96)00484-6.
- Iskander S, Iskandrian AE. Prognostic utility of myocardial viability assessment. Am J Cardiol. 1999 Mar 1;83(5):696-702, A7. doi: 10.1016/s0002-9149(98)00973-4.
- Carlos ME, Smart SC, Wynsen JC, Sagar KB. Dobutamine stress echocardiography for risk stratification after myocardial infarction. Circulation. 1997 Mar 18;95(6):1402-10. doi: 10.1161/01.cir.95.6.1402.
- Picano E, Sicari R, Landi P, Cortigiani L, Bigi R, Coletta C, Galati A, Heyman J, Mattioli R, Previtali M, Mathias W Jr, Dodi C, Minardi G, Lowenstein J, Seveso G, Pingitore A, Salustri A, Raciti M. Prognostic value of myocardial viability in medically treated patients with global left ventricular dysfunction early after an acute uncomplicated myocardial infarction: a dobutamine stress echocardiographic study. Circulation. 1998 Sep 15;98(11):1078-84. doi: 10.1161/01.cir.98.11.1078.
- Samad BA, Frick M, Hojer J, Urstad MJ. Early low-dose dobutamine echocardiography predicts late functional recovery after thrombolyzed acute myocardial infarction. Am Heart J. 1999 Mar;137(3):489-93. doi: 10.1016/s0002-8703(99)70497-7.
- Yoshida K, Gould KL. Quantitative relation of myocardial infarct size and myocardial viability by positron emission tomography to left ventricular ejection fraction and 3-year mortality with and without revascularization. J Am Coll Cardiol. 1993 Oct;22(4):984-97. doi: 10.1016/0735-1097(93)90407-r.
- Nijland F, Kamp O, Verhorst PM, de Voogt WG, Bosch HG, Visser CA. Myocardial viability: impact on left ventricular dilatation after acute myocardial infarction. Heart. 2002 Jan;87(1):17-22. doi: 10.1136/heart.87.1.17.
- Bax JJ, Wijns W, Cornel JH, Visser FC, Boersma E, Fioretti PM. Accuracy of currently available techniques for prediction of functional recovery after revascularization in patients with left ventricular dysfunction due to chronic coronary artery disease: comparison of pooled data. J Am Coll Cardiol. 1997 Nov 15;30(6):1451-60. doi: 10.1016/s0735-1097(97)00352-5.
- EPILOG Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. N Engl J Med. 1997 Jun 12;336(24):1689-96. doi: 10.1056/NEJM199706123362401.
- EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet. 1998 Jul 11;352(9122):87-92. doi: 10.1016/s0140-6736(98)06113-3.
- Montalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansieri M, Choussat R, Pinton P; ADMIRAL Investigators. Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-Term Follow-up. Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001 Jun 21;344(25):1895-903. doi: 10.1056/NEJM200106213442503.
- Steinhubl SR, Berger PB, Mann JT 3rd, Fry ET, DeLago A, Wilmer C, Topol EJ; CREDO Investigators. Clopidogrel for the Reduction of Events During Observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA. 2002 Nov 20;288(19):2411-20. doi: 10.1001/jama.288.19.2411. Erratum In: JAMA. 2003 Feb 26;289(8):987.
- Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, Bell WR, Knatterud G, Robertson TL, Terrin ML. Thrombolysis in Myocardial Infarction (TIMI) Trial--phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988 Jan;11(1):1-11. doi: 10.1016/0735-1097(88)90158-1.
- Weissman NJ, Levangie MW, Newell JB, Guerrero JL, Weyman AE, Picard MH. Effect of beta-adrenergic receptor blockade on the physiologic response to dobutamine stress echocardiography. Am Heart J. 1995 Aug;130(2):248-53. doi: 10.1016/0002-8703(95)90436-0.
- Schiller NB, Shah PM, Crawford M, DeMaria A, Devereux R, Feigenbaum H, Gutgesell H, Reichek N, Sahn D, Schnittger I, et al. Recommendations for quantitation of the left ventricle by two-dimensional echocardiography. American Society of Echocardiography Committee on Standards, Subcommittee on Quantitation of Two-Dimensional Echocardiograms. J Am Soc Echocardiogr. 1989 Sep-Oct;2(5):358-67. doi: 10.1016/s0894-7317(89)80014-8.
- van Loon RB, Veen G, Kamp O, Baur LH, van Rossum AC. Left ventricular remodeling after acute myocardial infarction: the influence of viability and revascularization - an echocardiographic substudy of the VIAMI-trial. Trials. 2014 Aug 18;15:329. doi: 10.1186/1745-6215-15-329.
- van Loon RB, Veen G, Baur LH, Kamp O, Bronzwaer JG, Twisk JW, Verheugt FW, van Rossum AC. Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial). Trials. 2012 Jan 3;13:1. doi: 10.1186/1745-6215-13-1.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2001年4月1日
研究完成
2007年1月1日
研究注册日期
首次提交
2005年9月6日
首先提交符合 QC 标准的
2005年9月6日
首次发布 (估计)
2005年9月8日
研究记录更新
最后更新发布 (估计)
2008年9月5日
上次提交的符合 QC 标准的更新
2008年9月4日
最后验证
2006年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.