Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being conducted in patients with a major heart attack caused by a blocked artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50% of people with an heart attack are found to have one or more additional narrowings that did not cause the heart attack. At present the best way to manage these additional blockages is not known. Many cardiologist recommend opening these blockages at at a later time after the heart attack. The present study is examining if PCI of all blockages at the same time as the PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI). Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and monitor adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same sitting complete revascularization | Experimental | After treatment of the IRA, subjects will undergo PCI of all suitable significant non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm). |
|
| Staged non-IRA PCI | Active Comparator | Only the IRA will be intervened upon during the index primary PCI procedure. Staging of the non-IRA lesions will be performed 48 hours to 45 days after the primary PCI procedure. All suitable non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm) will be treated with PCI irrespective of whether there are clinical symptoms or evidence of ischemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Same sitting PCI with complete revascularization | Procedure | revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting at the time of primary PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse clinical events | Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | 90 days | |
| Stroke | 90 days | |
| Contrast nephropathy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Val Panzov | Contact | 416-864-6060 | 7125 | panzovv@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Akshay Bagai, MD | Unity Health Toronto | Principal Investigator |
| Asim Cheema, MD | Unity Health Toronto | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Staged PCI with complete revsacularization >48 hours pf primary PCI | Procedure | revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting >48 hours to 45 days post primary PCI |
|
| 90 days |
| Major vascular complication | 90 days |
| EQ-5D quality of life assessment | 90 days |
| Incremental Cost-Effectiveness Ratio (ICER) | 90 days |
| Myocardial infarction | 90 days |
| Heart failure | 90 days |
| All cause mortality | 90 days |
| Unplanned revascularization | 90 days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |