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The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion.
In the setting of largely thrombotic lesions such as those treated in the context of primary PCI, stenting often results in distal micro and macro-embolisation which hampers coronary flow and microvascular recovery. Interestingly in some of these studies comparing BMS versus balloon angioplasty an early hazard associated to the use of stent has been reported.
Thus, investigators hypothesize in this protocol that refraining from stenting during the acute phase of ST segment myocardial infarction is safe and associated to improved myocardial recovery as compared to acute stenting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate stenting | Active Comparator | Patients being randomized to the immediate stenting arm will be managed according to the guidelines. Irrespective of TIMI flow at presentation, investigators will be requested to thrombus aspirate immediately after successful wiring of the culprit vessel followed by direct stenting. In cases where insertion of thrombus removal catheter and/or direct stenting is not successful, balloon angioplasty will be allowed. |
|
| Delayed stenting | Experimental | Patients being randomized to the delayed/staged stenting arm will be managed with the aim to obtain stable TIMI 3 flow with no considerations given at the percentage of residual stenosis at the culprit lesion. In patients presenting with TIMI 3 flow, investigators will be left free to wire the vessel and proceed to thrombus aspiration to decrease thrombus burden in the culprit lesion or to leave the vessel untreated at the time of index PCI. Patients presenting with suboptimal TIMI flow (i.e. less than 3), investigators are required to wire the vessel and thrombus aspirate. If stable (persisting for at least 5 minutes) TIMI 3 flow is obtained, investigators are requested to stop the procedure. The goal is to achieve s table TIMI 3 flow with no considerations given to the percentage of residual stenosis. Stenting in this arm will be allowed only on a bail-out strategy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate stenting | Procedure | Primary coronary stenting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial blush grade (MBG) equal or greater than 2 | The MBG will be estimated visually by 2 experienced observers, as previously described. | post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| ST segment elevation resolution | Cumulative ST segment elevation in all leads will be quantified before and after the procedure and expressed as percentage | 30 minutes after the procedure |
| ST segment elevation Resolution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Dal Monte, MD | Contact | 3487243479 | +39 | dalmo_it@yahoo.it |
| Marco Valgimigli, MD, PhD | Contact | 3356478877 | +39 | vlgmrc@unife.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. Cardiologia | Recruiting | Ferrara | Emilia-Romagna | 44100 | Italy |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Delayed stenting |
| Procedure |
Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase |
|
| 90 minutes after the procedure |
| infarct size | Infarct size will be quantified by MRI | 5 days |
| Infarct size | Infarct size will be quantified by MRI | 6 months |
| microvascular obstruction | microvascular obstruction will be quantified by MRI | 5 days |
| microvascular obstruction | microvascular obstruction will be quantified by MRI | 6 months |
| Mortality | overall and cardiac mortality will be assessed up to 6 months | 6 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |