Trial of routine angioplasty and stenting after fibrinolysis to enhance reperfusion in acute myocardial infarction: The TRANSFER-AMI trial
| ISRCTN | ISRCTN04467549 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04467549 |
| ClinicalTrials.gov number | NCT00164190 |
| Secondary identifying numbers | MCT-69798 |
- Submission date
- 09/09/2005
- Registration date
- 09/09/2005
- Last edited
- 25/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Warren Joseph Cantor
Scientific
Scientific
Interventional Cardiologist, Southlake Regional Health Centre
Assistant Professor of Medicine, University of Toronto
Medical Director, Interventional/Invasive Program, Southlake
641 Davis Drive
Newmarket, Ontario
L3Y 2R2
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Routine angioplasty and stenting after fibrinolysis to enhance reperfusion in acute myocardial infarction: a randomised controlled trial |
| Study acronym | TRANSFER-AMI |
| Study objectives | 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 ischaemia, 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. |
| Ethics approval(s) | St Michael's Hospital (Toronto) - Research Ethics Board Office of Research Administration approved on 21st July 2003 |
| Health condition(s) or problem(s) studied | Acute Myocardial Infarction |
| Intervention | 1. Facilitated Percutaneous Coronary Intervention (PCI) strategy: Full-dose weight-adjusted tenecteplase + unfractionated heparin or Enoxaparin (30 mg IV bolus + 1 mg/kg subcutaneously [sc]), followed by immediate transfer for cardiac catheterisation PCI 2. Thrombolysis with Provisional Rescue PCI: Full-dose weight-adjusted tenecteplase + unfractionated heparin or Enoxaparin (30 mg IV bolus + 1 mg/kg sc), bedside clinical assessment of reperfusion at 60 - 90 minutes, rescue PCI for patients with evidence of failed reperfusion |
| Intervention type | Other |
| Primary outcome measure | 30-day composite of: 1. Death (all cause) 2. Reinfarction 3. Recurrent ischaemia 4. New or Worsening Congestive Heart Failure, including readmission for heart failure 5. Development of cardiogenic shock requiring inotropic support or intra-aortic balloon pump insertion |
| Secondary outcome measures | 1. The incidence of major/severe bleeding, as defined by the TIMI and GUSTO bleeding classifications in the first 30 days 2. The proportion of patients with complete (greater than 70%) and partial (30 - 70%) ST-segment resolution from the qualifying ECG to 6 hours after randomisation 3. Infarct size as assessed by QRS scoring system on the 180 minute 12-lead electrocardiogram 4. The composite of death or reinfarction at 6 months 5. The composite of death or reinfarction at 1 year 6. Health costs |
| Overall study start date | 07/10/2004 |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1158 |
| Key inclusion criteria | 1158 persons with acute myocardial infarction of both sex, 18 years and older. Patients greater than or equal to 18 years old who present within 12 hours of symptom onset with more than 30 minutes of continuous symptoms of an acute myocardial infarction, with high risk characteristics, defined as either: 1. 2 mm ST-segment elevation in 2 or more contiguous anterior leads 2. 1 mm ST-segment elevation in 2 or more contiguous inferior leads with either: 2.1. Systolic blood pressure less than 100 mmHg 2.2. Heart Rate greater than 100/minute 2.3. Killip Class II - III 2.4. 2 mm ST-segment depression in anterior leads 2.5. 1 mm ST-segment elevation in right-sided lead V4 (V4R), indicative of right ventricular involvement |
| Key exclusion criteria | 1. Left Bundle Branch Block 2. Cardiogenic Shock (Killip Class IV) 3. Active bleeding or known haemorrhagic diathesis 4. Availability of Primary PCI with door-to- balloon time = 60 minutes 5. Time from thrombolysis to initiation of consent process greater than 30 minutes 6. Use of thrombolytic agent other than tenecteplase for index event 7. Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks 8. Systolic blood pressure greater than 200 mmHg or diastolic greater than 110 mmHg after arrival to the hospital and before enrolment 9. Concomitant use of oral anticoagulants (e.g. warfarin) with International Normalized Ratio (INR) of greater than 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 ischaemic 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 enrolment or prior participation in this study 15. Inability to cooperate with the protocol or undergo cardiac catheterisation 16. Other serious illness (e.g. active cancer, significant hepatic or renal disease) 17. Percutaneous coronary intervention within the prior month 18. Previous bypass surgery 19. Pregnancy |
| Date of first enrolment | 07/10/2004 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Interventional Cardiologist, Southlake Regional Health Centre
Newmarket, Ontario
L3Y 2R2
Canada
L3Y 2R2
Canada
Sponsor information
University of Toronto (Canada)
University/education
University/education
27 King's College Circle
Toronto
M5S 1A1
Canada
| Website | http://www.utoronto.ca/ |
|---|---|
"ROR" |
https://ror.org/03dbr7087 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-69798)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2008 | Yes | No |
