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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Netherlands Heart Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Interuniversity Cardiology Institute of the Netherlands
Eli Lilly and Company
Boehringer Ingelheim
Bristol-Myers Squibb
Information provided by:
Netherlands Heart Foundation
ClinicalTrials.gov Identifier:
NCT00149591
First received: September 6, 2005
Last updated: September 4, 2008
Last verified: September 2006
  Purpose

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.


Condition Intervention
Myocardial Infarction
Coronary Artery Disease
Procedure: coronary balloon-angioplasty with stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Netherlands Heart Foundation:

Primary Outcome Measures:
  • Death
  • Recurrent myocardial infarction
  • Unstable angina for which hospital admission required
  • Analysis at 30 days, 6 months and 1 year

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: April 2001
Estimated Study Completion Date: January 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149591

Locations
Netherlands
Medical Center Alkmaar (MCA)
Alkmaar, Netherlands, 1815 JD
VU University medical center
Amsterdam, Netherlands, 1081 HV
Sint LucasAndreas Hospital
Amsterdam, Netherlands, 1058 NR
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
Sponsors and Collaborators
Netherlands Heart Foundation
The Interuniversity Cardiology Institute of the Netherlands
Eli Lilly and Company
Boehringer Ingelheim
Bristol-Myers Squibb
Investigators
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 VU University Medical Center
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149591     History of Changes
Other Study ID Numbers: 2000B026, H4S-UT-O017
Study First Received: September 6, 2005
Last Updated: September 4, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Netherlands Heart Foundation:
Myocardial infarction
Viability
Coronary angioplasty
Prevention
Prognosis

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014