Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction

October 14, 2010 updated by: Canadian Heart Research Centre

Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction- The TRANSFER-AMI Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2R2
        • Southlake Regional Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30-day composite of death (all cause)
Time Frame: 30 day
30 day
Reinfarction
Time Frame: 30 day
30 day
Recurrent ischemia
Time Frame: 30 day
30 day
New or worsening congestive heart failure, including readmission for heart failure
Time Frame: 30 day
30 day
Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion
Time Frame: 30 day
30 day

Secondary Outcome Measures

Outcome Measure
Time Frame
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
30 day
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
30 day
Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram
Time Frame: 30 day
30 day
The composite of death or reinfarction at 6 months
Time Frame: 30 day
30 day
The composite of death or reinfarction at 1 year
Time Frame: 30 day
30 day
Health costs
Time Frame: 30 day
30 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Heart Research Centre

Collaborators

Canadian Institutes of Health Research (CIHR)
Hoffmann-La Roche
Guidant Corporation

Investigators

  • Principal Investigator: Warren J. Cantor, MD, Caribbean Health Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

October 18, 2010

Last Update Submitted That Met QC Criteria

October 14, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-69798
  • FRN:69798

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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