Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT00164190|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 18, 2010
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.
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).
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.
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 or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Procedure: Routine Early Percutaneous Coronary Intervention after Thrombolysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction- The TRANSFER-AMI Trial|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||January 2009|
Procedure: Routine Early Percutaneous Coronary Intervention after Thrombolysis
- 30-day composite of death (all cause) [ Time Frame: 30 day ]
- Reinfarction [ Time Frame: 30 day ]
- Recurrent ischemia [ Time Frame: 30 day ]
- New or worsening congestive heart failure, including readmission for heart failure [ Time Frame: 30 day ]
- Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion [ Time Frame: 30 day ]
- 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 ]
- 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 ]
- Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram [ Time Frame: 30 day ]
- The composite of death or reinfarction at 6 months [ Time Frame: 30 day ]
- The composite of death or reinfarction at 1 year [ Time Frame: 30 day ]
- Health costs [ Time Frame: 30 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164190
|Southlake Regional Health Centre|
|Newmarket, Ontario, Canada, L3Y 2R2|
|Principal Investigator:||Warren J. Cantor, MD||Caribbean Health Research Council|