Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164190
Status:
COMPLETED
Last Update Posted:
2010-10-18
First Post:
2005-09-09
Brief Title:
Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction
Sponsor:
Canadian Heart Research Centre
Organization:
Canadian Heart Research Centre
Study Overview
Official Title:
Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction- The TRANSFER-AMI Trial
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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 andor development of cardiogenic shock The primary endpoint will be the composite of death reinfarction recurrent ischemia heart failure and shock at 30 days
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 andor 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 andor development of cardiogenic shock The primary endpoint will be the composite of death reinfarction recurrent ischemia heart failure and shock at 30 days
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 andor development of cardiogenic shock
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FRN69798 | None | None | None |