The Viability-Guided Angioplasty After Acute Myocardial Infarction-Trial (The VIAMI-Trial)

Coronary Artery Disease Clinical Trial

Official title:

Early and Long-Term Outcome of Elective Stenting of the Infarct-Related Artery in Patients With Viability in the Infarct-Area Early After Acute Myocardial Infarction. The VIAMI-Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00149591
• Other study ID #: 2000B026
• Secondary ID: H4S-UT-O017
• Status: Active, not recruiting
• Phase: N/A
• First received: September 6, 2005
• Last updated: September 4, 2008
• Start date: April 2001
• Est. completion date: January 2007

Study information

• Verified date: September 2006
• Source: Netherlands Heart Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The VIAMI-trial investigates the effects of balloon angioplasty with stenting of the infarct-vessel in the early phase after acute myocardial infarction. The study concerns patients who have residual viable tissue in the infarct-area after being treated with thrombolysis. It is postulated that only patients with remaining viable tissue are at high-risk for recurrent infarction or anginal attacks and that stenting of the infarct-vessel will reduce this risk considerably.

Description:

Earlier studies have shown that routine angioplasty of the infarct-related coronary artery soon after thrombolysis for acute myocardial infarction did not result in a clinical benefit. This finding emphasizes the importance to select a subgroup of patients with a recent myocardial infarction, who will really benefit from angioplasty of the infarct-related artery.

Several studies have demonstrated that the presence of viability in the infarct-area early after acute myocardial infarction imposes an increased risk of new cardiac events like recurrent infarction, angina pectoris and need for coronary interventions. Therefore, it is postulated that only patients with viability in the infarct-area will benefit from angioplasty early after acute myocardial infarction.

In the VIAMI-trial patients who are admitted to the hospital with an acute myocardial infarction and who did not undergo immediate coronary angioplasty, will undergo viability testing by dobutamine-echocardiography within 3 days of admission. Patients with unequivocal signs of viability in the infarct-area will then be randomized to an invasive or a conservative treatment strategy. In the invasive strategy patients will undergo coronary angiography with the intention to perform balloon angioplasty with stenting of the infarct-related coronary artery, with concomitant use of the intravenous platelet inhibitor abciximab. In the conservative group patients will undergo coronary angiography and angioplasty only when new impending infarction or recurrent ischemia is present. In the invasive group balloon angioplasty will be performed as soon as possible after randomization. Patients without viability will not be randomized,but will participate as a control group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Admission within 6 hours of pain onset and EKG with = 1 mm ST-segment elevation in two or more standard leads or = 2 mm ST-elevation in two contiguous chest leads, indicative for transmural ischemia, with or without the development of new Q-waves, with myocardial necrosis proven by enzyme rise (total CPK = 2x the upper normal limit).

• Patient history compatible with subacute myocardial infarction ( = 6 hours), with at least signs of myocardial necrosis on the EKG (Q-waves) and a significantly increased serum level of cardiac-specific enzymes.

• Age between 18 and 80 years.

• Viability testing performed prior to coronary angiography.

• No clinical indication for an invasive procedure to be performed before viability testing

Exclusion Criteria:

• No informed consent obtained

• Unreliable follow-up

• Viability testing technically not possible

• Contra-indications for dobutamine echocardiography (heart failure, arrhythmia)

• Contra-indications for coronary angiography, such as severe diabetic nephropathy or know contrast-allergy

• Known hypersensitivity for abciximab

• Serious, life-threatening non-cardiac illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• coronary balloon-angioplasty with stenting

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar (MCA)	Alkmaar
Netherlands	Sint LucasAndreas Hospital	Amsterdam
Netherlands	VU University medical center	Amsterdam
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Kennemer Gasthuis	Haarlem
Netherlands	Atrium Medical Center Heerlen	Heerlen
Netherlands	Hospital Hilversum	Hilversum
Netherlands	Rijnland Hospital	Leiderdorp
Netherlands	University Medical Center St. Radboud	Nijmegen
Netherlands	Waterland Hospital	Purmerend
Netherlands	Diakonessenhuis	Utrecht
Netherlands	Zaans Medical Center "De Heel"	Zaandam

Sponsors (5)

Lead Sponsor	Collaborator
Netherlands Heart Foundation	Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, The Interuniversity Cardiology Institute of the Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (46)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. The TIMI Study Group. N Engl J Med. 1989 Mar 9;320(10):618-27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. Lancet. 1990 Jul 14;336(8707):65-71. — View Citation

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. — View Citation

Gunnar RM, Passamani ER, Bourdillon PD, Pitt B, Dixon DW, Rapaport E, Fuster V, Reeves TJ, Karp RB, Russell RO Jr, et al. Guidelines for the early management of patients with acute myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee to Develop Guidelines for the Early Management of Patients with Acute Myocardial Infarction). J Am Coll Cardiol. 1990 Aug;16(2):249-92. Review. — View Citation

Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201. — View Citation

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. — View Citation

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. — View Citation

Iskander S, Iskandrian AE. Prognostic utility of myocardial viability assessment. Am J Cardiol. 1999 Mar 1;83(5):696-702, A7. Review. — View Citation

Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. Review. — View Citation

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. — View Citation

Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. — View Citation

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. — View Citation

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. — View Citation

Montalescot G, Barragan P, Wittenberg O, Ecollan P, Elhadad S, Villain P, Boulenc JM, Morice MC, Maillard L, Pansiéri 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Samad BA, Frick M, Höjer 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2003 Feb 26;289(8):987.. — View Citation

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. — View Citation

The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. The GUSTO Angiographic Investigators. N Engl J Med. 1993 Nov 25;329(22):1615-22. Erratum in: N Engl J Med 1994 Feb 17;330(7):516. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Veen G, Meyer A, Verheugt FW, Werter CJ, de Swart H, Lie KI, van der Pol JM, Michels HR, van Eenige MJ. Culprit lesion morphology and stenosis severity in the prediction of reocclusion after coronary thrombolysis: angiographic results of the APRICOT study. Antithrombotics in the Prevention of Reocclusion in Coronary Thrombolysis. J Am Coll Cardiol. 1993 Dec;22(7):1755-62. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death
Primary	Recurrent myocardial infarction
Primary	Unstable angina for which hospital admission required
Primary	Analysis at 30 days, 6 months and 1 year
Secondary	Left ventricular function (Echocardiography)
Secondary	Incidence of heart failure (NYHA)
Secondary	Angina pectoris class (CCS)
Secondary	Need for revascularization procedures
Secondary	Analysis at 3 and 6 months and after 1 year

External Links

•   Click here for more information about this study