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.
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Netherlands Heart Foundation | Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, The Interuniversity Cardiology Institute of the Netherlands |
Netherlands,
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* Note: There are 46 references in all — Click here to view all references
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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