The Viability-Guided Angioplasty After Acute Myocardial Infarction-Trial (The VIAMI-Trial)
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ClinicalTrials.gov Identifier: NCT00149591 |
Recruitment Status : Unknown
Verified September 2006 by Netherlands Heart Foundation.
Recruitment status was: Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : September 5, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Coronary Artery Disease | Procedure: coronary balloon-angioplasty with stenting | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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. |
Study Start Date : | April 2001 |
Study Completion Date : | January 2007 |

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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149591
Netherlands | |
Medical Center Alkmaar (MCA) | |
Alkmaar, Netherlands, 1815 JD | |
Sint LucasAndreas Hospital | |
Amsterdam, Netherlands, 1058 NR | |
VU University medical center | |
Amsterdam, Netherlands, 1081 HV | |
Catharina Hospital | |
Eindhoven, Netherlands, 5623 EJ | |
Kennemer Gasthuis | |
Haarlem, Netherlands, 2000 AK | |
Atrium Medical Center Heerlen | |
Heerlen, Netherlands, 6401 CX | |
Hospital Hilversum | |
Hilversum, Netherlands, 1213 XZ | |
Rijnland Hospital | |
Leiderdorp, Netherlands, 2350 CC | |
University Medical Center St. Radboud | |
Nijmegen, Netherlands, 6525 GA | |
Waterland Hospital | |
Purmerend, Netherlands, 1441 RN | |
Diakonessenhuis | |
Utrecht, Netherlands, 3582 KE | |
Zaans Medical Center "De Heel" | |
Zaandam, Netherlands, 1500 EE |
Principal Investigator: | Gerrit Veen, MD, PhD | VU University medical center, Amsterdam, The Netherlands | |
Study Chair: | Cees A Visser, MD, PhD | VU University medical center, Amsterdam, The Netherlands | |
Study Director: | Frans C Visser, MD, PhD | Amsterdam UMC, location VUmc |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00149591 |
Other Study ID Numbers: |
2000B026 H4S-UT-O017 |
First Posted: | September 8, 2005 Key Record Dates |
Last Update Posted: | September 5, 2008 |
Last Verified: | September 2006 |
Myocardial infarction Viability Coronary angioplasty Prevention Prognosis |
Coronary Artery Disease Myocardial Infarction Infarction Ischemia Pathologic Processes Necrosis Coronary Disease |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |