Myocardial InfarctionNCT00164190
Routine Angioplasty and Stenting After Fibrinolysis for Acute Myocardial Infarction
A study testing Routine Early Percutaneous Coronary Intervention after Thrombolysis in people with Myocardial Infarction, run by Canadian Heart Research Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Routine Early Percutaneous Coronary Intervention after Thrombolysis
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2004to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Left bundle branch block
- Cardiogenic shock (Killip Class IV requiring vasopressors or inotropic support to maintain a systolic blood pressure > 90) prior to randomization
- Active bleeding or known hemorrhagic diathesis
- Availability of primary PCI with door-to-balloon time ≤ 60 minutes
- Time from thrombolysis to initiation of consent process > 30 minutes
- Use of thrombolytic agent other than tenecteplase (TNK) for index event
Show all 22Show fewer
- Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks
- Systolic blood pressure > 200 mm Hg or diastolic > 110 mm Hg after arrival to the hospital and before enrollment
- Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of > 2
- Recent non-compressible vascular puncture
- 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
- History of heparin-induced thrombocytopenia
- Documented allergy to aspirin
- Participation in other clinical research studies involving experimental therapies including drugs or devices within 7 days of enrollment or prior participation in this study
- Inability to cooperate with the protocol or undergo cardiac catheterization
- Other serious illness (e.g. active cancer, significant hepatic disease)
- Serum creatinine > 140 umol/L
- Percutaneous coronary intervention within one month
- Previous bypass surgery
- Pregnancy
- Use of enoxaparin (or other low molecular weight heparin) in last 12 hours in patient > 75 years of age
- Inferior ST-elevation myocardial infarction with none of the 5 high-risk features listed in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Routine Early Percutaneous Coronary Intervention after Thrombolysis
- Keywords
- Myocardial Infarction, Thrombolysis, Angioplasty, ST Elevation Myocardial Infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Early Percutaneous Coronary Intervention after ThrombolysisProcedure or surgery
early or delayed PCI
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day composite of death (all cause)
Measured: 30 day
Reinfarction
Measured: 30 day
Recurrent ischemia
Measured: 30 day
New or worsening congestive heart failure, including readmission for heart failure
Measured: 30 day
Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion
Measured: 30 day
Secondary outcomes (6)
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
Measured: 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
Measured: 30 day
Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram
Measured: 30 day
The composite of death or reinfarction at 6 months
Measured: 30 day
The composite of death or reinfarction at 1 year
Measured: 30 day
Health costs
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Heart Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Hoffmann-La Roche, Guidant Corporation
- Investigators
- Warren J. Cantor, MD, Principal investigator, Caribbean Health Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164190
- Sponsor's protocol ID
- MCT-69798
- Other IDs
- FRN:69798
- Status last verified
- Oct 2010
- First submitted
- 9 Sep 2005
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arbel Y, Ko DT, Yan AT, Cantor WJ, Bagai A, Koh M, Eberg M, Tan M, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Morrison LJ, Langer A, Dzavik V, Mehta SR, Goodman SG; TRANSFER-AMI Trial Investigators. Long-term Follow-up of the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Can J Cardiol. 2018 Jun;34(6):736-743. doi: 10.1016/j.cjca.2018.02.005. Epub 2018 Feb 10.
PubMed 29801739Russo JJ, Goodman SG, Cantor WJ, Tan MK, Borgundvaag B, Fitchett D, Dzavik V, Yan RT, Graham JJ, Mehta SR, Yan AT; TRANSFER-AMI Investigators. Efficacy and safety of a routine early invasive strategy in relation to time from symptom onset to fibrinolysis (a subgroup analysis of TRANSFER-AMI). Am J Cardiol. 2015 Apr 15;115(8):1005-12. doi: 10.1016/j.amjcard.2015.01.533. Epub 2015 Jan 31.
PubMed 25711435Russo JJ, Goodman SG, Cantor WJ, Fitchett D, Heffernan M, Borgundvaag B, Ducas J, Cohen EA, Dzavik V, Mehta SR, Buller CE, Yan AT; TRANSFER-AMI investigators. Efficacy and safety of a routine early invasive strategy after fibrinolysis stratified by glycoprotein IIb/IIIa inhibitor use during percutaneous coronary intervention: a pre-specified subgroup analysis of the TRANSFER-AMI randomised controlled trial. Heart. 2014 Jun;100(11):873-80. doi: 10.1136/heartjnl-2013-305231. Epub 2014 Jan 21.
PubMed 24449716Bagai A, Cantor WJ, Tan M, Tong W, Lamy A, Fitchett D, Cohen EA, Mehta SR, Borgundvaag B, Ducas J, Heffernan M, Dzavik V, Morrison L, Schwartz B, Lazzam C, Langer A, Goodman SG. Clinical outcomes and cost implications of routine early PCI after fibrinolysis: one-year follow-up of the Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) study. Am Heart J. 2013 Apr;165(4):630-637.e2. doi: 10.1016/j.ahj.2012.12.016. Epub 2013 Feb 19.
PubMed 23537982Bhan V, Cantor WJ, Yan RT, Mehta SR, Morrison LJ, Heffernan M, Fitchett D, Dzavik V, Ducas J, Borgundvaag B, Cohen EA, Goodman SG, Yan AT. Efficacy of early invasive management post-fibrinolysis in men versus women with ST-elevation myocardial infarction: a subgroup analysis from Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Am Heart J. 2012 Sep;164(3):343-50. doi: 10.1016/j.ahj.2012.05.022. Epub 2012 Aug 17.
PubMed 22980300Lavi S, Cantor WJ, Casanova A, Tan MK, Yan AT, Dzavik V, Fitchett D, Cohen EA, Borgundvaag B, Heffernan M, Ducas J, Goodman SG. Efficacy and safety of enoxaparin compared with unfractionated heparin in the pharmacoinvasive management of acute ST-segment elevation myocardial infarction: Insights from the TRANSFER-AMI trial. Am Heart J. 2012 Feb;163(2):176-81.e2. doi: 10.1016/j.ahj.2011.10.015.
PubMed 22305834Yan AT, Yan RT, Cantor WJ, Borgundvaag B, Cohen EA, Fitchett DH, Dzavik V, Ducas J, Tan M, Casanova A, Goodman SG; TRANSFER-AMI Investigators. Relationship between risk stratification at admission and treatment effects of early invasive management following fibrinolysis: insights from the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Eur Heart J. 2011 Aug;32(16):1994-2002. doi: 10.1093/eurheartj/ehr008. Epub 2011 Feb 8.
PubMed 21307037Cantor WJ, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Cohen EA, Morrison LJ, Langer A, Dzavik V, Mehta SR, Lazzam C, Schwartz B, Casanova A, Goodman SG; TRANSFER-AMI Trial Investigators. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med. 2009 Jun 25;360(26):2705-18. doi: 10.1056/NEJMoa0808276.
PubMed 19553646
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction- The TRANSFER-AMI Trial
- ClinicalTrials.gov ID
- NCT00164190
- Acronym / sponsor ID
- MCT-69798
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Thrombolysis, Angioplasty, ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Canadian Heart Research CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Hoffmann-La Roche, Guidant Corporation
- Study start
- Jul 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (22 listed)
- Left bundle branch block
- Cardiogenic shock (Killip Class IV requiring vasopressors or inotropic support to maintain a systolic blood pressure > 90) prior to randomization
- Active bleeding or known hemorrhagic diathesis
- Availability of primary PCI with door-to-balloon time ≤ 60 minutes
- Time from thrombolysis to initiation of consent process > 30 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Early Percutaneous Coronary Intervention after Thrombolysisearly or delayed PCI | Procedure or surgery | – |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2010.
- Derived from this study: PubMed 29801739Arbel Y, Ko DT, Yan AT, Cantor WJ, Bagai A, Koh M, Eberg M, Tan M, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Morrison LJ, Langer A, Dzavik V, Mehta SR, Goodman SG; TRANSFER-AMI Trial Investigators. Long-term Follow-up of the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Can J Cardiol. 2018 Jun;34(6):736-743. doi: 10.1016/j.cjca.2018.02.005. Epub 2018 Feb 10.
- Derived from this study: PubMed 25711435Russo JJ, Goodman SG, Cantor WJ, Tan MK, Borgundvaag B, Fitchett D, Dzavik V, Yan RT, Graham JJ, Mehta SR, Yan AT; TRANSFER-AMI Investigators. Efficacy and safety of a routine early invasive strategy in relation to time from symptom onset to fibrinolysis (a subgroup analysis of TRANSFER-AMI). Am J Cardiol. 2015 Apr 15;115(8):1005-12. doi: 10.1016/j.amjcard.2015.01.533. Epub 2015 Jan 31.
- Derived from this study: PubMed 24449716Russo JJ, Goodman SG, Cantor WJ, Fitchett D, Heffernan M, Borgundvaag B, Ducas J, Cohen EA, Dzavik V, Mehta SR, Buller CE, Yan AT; TRANSFER-AMI investigators. Efficacy and safety of a routine early invasive strategy after fibrinolysis stratified by glycoprotein IIb/IIIa inhibitor use during percutaneous coronary intervention: a pre-specified subgroup analysis of the TRANSFER-AMI randomised controlled trial. Heart. 2014 Jun;100(11):873-80. doi: 10.1136/heartjnl-2013-305231. Epub 2014 Jan 21.
- Derived from this study: PubMed 23537982Bagai A, Cantor WJ, Tan M, Tong W, Lamy A, Fitchett D, Cohen EA, Mehta SR, Borgundvaag B, Ducas J, Heffernan M, Dzavik V, Morrison L, Schwartz B, Lazzam C, Langer A, Goodman SG. Clinical outcomes and cost implications of routine early PCI after fibrinolysis: one-year follow-up of the Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) study. Am Heart J. 2013 Apr;165(4):630-637.e2. doi: 10.1016/j.ahj.2012.12.016. Epub 2013 Feb 19.
- Derived from this study: PubMed 22980300Bhan V, Cantor WJ, Yan RT, Mehta SR, Morrison LJ, Heffernan M, Fitchett D, Dzavik V, Ducas J, Borgundvaag B, Cohen EA, Goodman SG, Yan AT. Efficacy of early invasive management post-fibrinolysis in men versus women with ST-elevation myocardial infarction: a subgroup analysis from Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Am Heart J. 2012 Sep;164(3):343-50. doi: 10.1016/j.ahj.2012.05.022. Epub 2012 Aug 17.
- Derived from this study: PubMed 22305834Lavi S, Cantor WJ, Casanova A, Tan MK, Yan AT, Dzavik V, Fitchett D, Cohen EA, Borgundvaag B, Heffernan M, Ducas J, Goodman SG. Efficacy and safety of enoxaparin compared with unfractionated heparin in the pharmacoinvasive management of acute ST-segment elevation myocardial infarction: Insights from the TRANSFER-AMI trial. Am Heart J. 2012 Feb;163(2):176-81.e2. doi: 10.1016/j.ahj.2011.10.015.
- Derived from this study: PubMed 21307037Yan AT, Yan RT, Cantor WJ, Borgundvaag B, Cohen EA, Fitchett DH, Dzavik V, Ducas J, Tan M, Casanova A, Goodman SG; TRANSFER-AMI Investigators. Relationship between risk stratification at admission and treatment effects of early invasive management following fibrinolysis: insights from the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI). Eur Heart J. 2011 Aug;32(16):1994-2002. doi: 10.1093/eurheartj/ehr008. Epub 2011 Feb 8.
- Derived from this study: PubMed 19553646Cantor WJ, Fitchett D, Borgundvaag B, Ducas J, Heffernan M, Cohen EA, Morrison LJ, Langer A, Dzavik V, Mehta SR, Lazzam C, Schwartz B, Casanova A, Goodman SG; TRANSFER-AMI Trial Investigators. Routine early angioplasty after fibrinolysis for acute myocardial infarction. N Engl J Med. 2009 Jun 25;360(26):2705-18. doi: 10.1056/NEJMoa0808276.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren J. Cantor, MD principal investigator
Caribbean Health Research Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Early Percutaneous Coronary Intervention after Thrombolysis in people with Myocardial Infarction, run by Canadian Heart Research Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day composite of death (all cause) (time frame: 30 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00164190, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2010.