Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hoffmann-La Roche
Guidant Corporation
Information provided by:
Canadian Heart Research Centre
ClinicalTrials.gov Identifier:
NCT00164190
First received: September 9, 2005
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

Background:

In Canada, most patients with acute myocardial infarction (AMI) present to hospitals without cardiac catheterization facilities. Thrombolytic therapy remains the standard-of-care in these centres. However, thrombolytic therapy achieves normal coronary flow and myocardial perfusion in less than 50% of patients, and is associated with reocclusion, reinfarction, and recurrent ischemia. Primary angioplasty results in more complete reperfusion and lower rates of reocclusion, reinfarction and recurrent ischemia, but is not available in most centres. Although patients can be transferred for primary angioplasty, long transport times are associated with worse outcomes. An alternative strategy, described as facilitated angioplasty, involves administration of thrombolytic therapy at the community hospital followed by immediate transport for angioplasty. This approach achieves the benefits of primary angioplasty without delaying treatment. A well-conducted, prospective, randomized trial is needed to compare this strategy of facilitated angioplasty with standard thrombolytic therapy.

Objectives:

To evaluate the safety, feasibility, and efficacy of routine transfer of patients with AMI to an angioplasty centre immediately after thrombolysis for coronary angiography and percutaneous coronary intervention (PCI).

Hypothesis:

A strategy of routine transfer of patients with AMI to an angioplasty centre immediately after thrombolysis for coronary angiography and percutaneous intervention is associated with a significantly lower incidence of the composite of death, reinfarction, recurrent ischemia, heart failure, and shock at 30 days compared with the conventional strategy of thrombolysis with transfer reserved for failed reperfusion and/or development of shock.

Research Plan:

Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to community hospitals without cardiac catheterization facilities will receive thrombolysis with tenecteplase and heparin (unfractionated or low molecular weight heparin) and will then be randomized to one of two strategies: facilitated PCI or standard treatment (thrombolysis with provisional rescue PCI). In the facilitated PCI group, patients will be transferred immediately to an angioplasty centre for urgent cardiac catheterization, and PCI if appropriate. In the standard treatment group, patients will only undergo urgent angiography for evidence of failed reperfusion and/or development of cardiogenic shock. The primary endpoint will be the composite of death, reinfarction, recurrent ischemia, heart failure, and shock at 30 days.


Condition Intervention
Myocardial Infarction
Procedure: Routine Early Percutaneous Coronary Intervention after Thrombolysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction- The TRANSFER-AMI Trial

Resource links provided by NLM:


Further study details as provided by Canadian Heart Research Centre:

Primary Outcome Measures:
  • 30-day composite of death (all cause) [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Reinfarction [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Recurrent ischemia [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • New or worsening congestive heart failure, including readmission for heart failure [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion [ Time Frame: 30 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of major/severe bleeding, as defined by the thrombolysis in myocardial ischemia (TIMI) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding classifications in the first 30 days [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • The proportion of patients with complete (> 70%) and partial (30-70%) ST-segment resolution from the qualifying electrocardiogram (ECG) to 6 hours after randomization [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • The composite of death or reinfarction at 6 months [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • The composite of death or reinfarction at 1 year [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Health costs [ Time Frame: 30 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: July 2004
Study Completion Date: January 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Routine Early Percutaneous Coronary Intervention after Thrombolysis
    early or delayed PCI
Detailed Description:

Patients with ST-elevation myocardial infarction and high-risk characteristics presenting to community hospitals without cardiac catheterization facilities will receive thrombolysis with tenecteplase and heparin (unfractionated or low molecular weight heparin) and will then be randomized to one of two strategies: facilitated percutaneous coronary intervention (PCI) or standard treatment (thrombolysis with provisional rescue PCI). In the facilitated PCI group, patients will be transferred immediately to an angioplasty centre for urgent cardiac catheterization, and PCI if appropriate within 6 hours of thrombolysis. In the standard treatment group, patients will only undergo urgent angiography for evidence of failed reperfusion and/or development of cardiogenic shock.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients >= 18 years old who present within 12 hours of symptom onset with more than 30 minutes of continuous symptoms of an acute myocardial infarction to a centre that does not perform primary PCI, with either:

  • >= 2 mm ST-segment elevation in 2 or more contiguous anterior leads
  • >= 1 mm ST-segment elevation in 2 or more contiguous inferior leads with at least one of the following high-risk features:

    • Systolic blood pressure < 100 mm Hg
    • Heart rate > 100/minute
    • Killip Class II-III
    • >= 2 mm ST-segment depression in anterior leads
    • >= 1 mm ST-segment elevation in right-sided lead V4 (V4R), indicative of right ventricular involvement

Exclusion Criteria:

  1. Left bundle branch block
  2. Cardiogenic shock (Killip Class IV requiring vasopressors or inotropic support to maintain a systolic blood pressure > 90) prior to randomization
  3. Active bleeding or known hemorrhagic diathesis
  4. Availability of primary PCI with door-to-balloon time ≤ 60 minutes
  5. Time from thrombolysis to initiation of consent process > 30 minutes
  6. Use of thrombolytic agent other than tenecteplase (TNK) for index event
  7. Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks
  8. Systolic blood pressure > 200 mm Hg or diastolic > 110 mm Hg after arrival to the hospital and before enrollment
  9. Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of > 2
  10. Recent non-compressible vascular puncture
  11. History of central nervous system structural damage (e.g. aneurysm, neoplasm, arteriovenous malformation, stroke) at any time, or transient ischemic attack within the last year
  12. History of heparin-induced thrombocytopenia
  13. Documented allergy to aspirin
  14. Participation in other clinical research studies involving experimental therapies including drugs or devices within 7 days of enrollment or prior participation in this study
  15. Inability to cooperate with the protocol or undergo cardiac catheterization
  16. Other serious illness (e.g. active cancer, significant hepatic disease)
  17. Serum creatinine > 140 umol/L
  18. Percutaneous coronary intervention within one month
  19. Previous bypass surgery
  20. Pregnancy
  21. Use of enoxaparin (or other low molecular weight heparin) in last 12 hours in patient > 75 years of age
  22. Inferior ST-elevation myocardial infarction with none of the 5 high-risk features listed in the inclusion criteria
  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: NCT00164190

Locations
Canada, Ontario
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2R2
Sponsors and Collaborators
Canadian Heart Research Centre
Canadian Institutes of Health Research (CIHR)
Hoffmann-La Roche
Guidant Corporation
Investigators
Principal Investigator: Warren J. Cantor, MD Caribbean Health Research Council
  More Information

No publications provided by Canadian Heart Research Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Warren Cantor, Canadian Heart Research Centre
ClinicalTrials.gov Identifier: NCT00164190     History of Changes
Other Study ID Numbers: MCT-69798, FRN:69798
Study First Received: September 9, 2005
Last Updated: October 14, 2010
Health Authority: Canada: Health Canada

Keywords provided by Canadian Heart Research Centre:
Myocardial Infarction
Thrombolysis
Angioplasty
ST Elevation Myocardial Infarction

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on October 19, 2014