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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
Est. primary completion date
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


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

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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

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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

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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 allClick 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
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