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

NCT00149591 | Unknown

• 2 other identifiers: 2000B026H4S-UT-O017
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Myocardial Infarction; Coronary Artery Disease

Keywords

Myocardial infarction; Viability; Coronary angioplasty; Prevention; Prognosis

Outcome Measures

Primary Outcomes (4)

• Death

• Recurrent myocardial infarction

• Unstable angina for which hospital admission required

• Analysis at 30 days, 6 months and 1 year

Secondary Outcomes (5)

• 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

Interventions

coronary balloon-angioplasty with stenting PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Netherlands Heart Foundation: lead
• The Interuniversity Cardiology Institute of the Netherlands: collaborator
• Eli Lilly and Company: collaborator
• Boehringer Ingelheim: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (12)

Medical Center Alkmaar (MCA)

Alkmaar, 1815 JD, Netherlands

Location

Sint LucasAndreas Hospital

Amsterdam, 1058 NR, Netherlands

Location

VU University medical center

Amsterdam, 1081 HV, Netherlands

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

Kennemer Gasthuis

Haarlem, 2000 AK, Netherlands

Location

Atrium Medical Center Heerlen

Heerlen, 6401 CX, Netherlands

Location

Hospital Hilversum

Hilversum, 1213 XZ, Netherlands

Location

Rijnland Hospital

Leiderdorp, 2350 CC, Netherlands

Location

University Medical Center St. Radboud

Nijmegen, 6525 GA, Netherlands

Location

Waterland Hospital

Purmerend, 1441 RN, Netherlands

Location

Diakonessenhuis

Utrecht, 3582 KE, Netherlands

Location

Zaans Medical Center "De Heel"

Zaandam, 1500 EE, Netherlands

Location

Related Publications (48)

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• van Loon RB, Veen G, Kamp O, Baur LH, van Rossum AC. Left ventricular remodeling after acute myocardial infarction: the influence of viability and revascularization - an echocardiographic substudy of the VIAMI-trial. Trials. 2014 Aug 18;15:329. doi: 10.1186/1745-6215-15-329.

  PMID: 25135364 DERIVED

• van Loon RB, Veen G, Baur LH, Kamp O, Bronzwaer JG, Twisk JW, Verheugt FW, van Rossum AC. Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial). Trials. 2012 Jan 3;13:1. doi: 10.1186/1745-6215-13-1.

  PMID: 22214287 DERIVED

Related Links

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MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Interventions

Angioplasty, Balloon; Stents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Study Officials

• Gerrit Veen, MD, PhD

  VU University medical center, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Cees A Visser, MD, PhD

  VU University medical center, Amsterdam, The Netherlands

  STUDY CHAIR

• Frans C Visser, MD, PhD

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: April 1, 2001
• Study Completion: January 1, 2007
• Last Updated: September 5, 2008

Record last verified: 2006-09

Locations

NL (12)