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Patients with anterior wall AMI treated by PCI will undergo, after successful revascularization of the infarct artery, measurement of the left ventricular pressure, and femoral angiogram. Patients with elevated LV pressure and adequate femoral access will be randomized to standard pharmacological treatment of AMI vs. mechanical unloading by Impella-CP (on top of the standard treatment) for 36-48 hours. LV unloading will be guided by measurement of PCWP by Swan-Ganz catheter. On the day 4-7, and at 3 months after the AMI, the patients will undergo SPECT and 3D-echocardiography to assess ventricular remodeling and extent of the post-infarct scar. The patients will be followed for at least 12 months for the occurrence of heart failure and adverse cardiovascular events. The study will test the hypothesis, whether the LV mechanical unloading after PCI will attenuate post-infarct scar and cardiac remodeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical unloading | Active Comparator | Mechanical unloading by Impella-CP for 36-48 hours, on top of the standard treatment |
|
| Standard care | No Intervention | Standard treatment of AMI after PCI according to guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LV mechanical unloading by Impella-CP | Procedure | The patients will receive Impella-CP for 36-48 hours. The pump speed and LV unloading will be guided by PCWP (Swan-Ganz catheter) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the left ventricular end-systolic volume | Absolute change in the LVESV measured by SPECT and compared between the groups | LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months |
| Occurrence of LV remodeling | Occurrence of LV remodeling defined by the increase of LV end-systolic volume >20% | LV end-systolic volume measured during the index hospitalization (day 5-7) and at 3 months |
| Extent of post-infarct scar | Extent of post-infarct scar measured by Tc-SPECT and compared between the groups | LV scar extent measured during the index hospitalization (day 5-7) and at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| CV complications | occurence of TIMI bleeding, hemolysis, thromboembolic events | during the first 5 day after AMI |
| heart failure | acute heart failure requiring inotropes or progression of cardiogenic shock |
| Measure | Description | Time Frame |
|---|---|---|
| self-assessed dyspnea | dyspnea reported by the patient on a Likert scale | day 1, 2 and 5 |
| lung water | assessment of lung water score by ultrasound |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marek Sramko, MD, PhD | Contact | +420731682681 | marek.sramko@ikem.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical and Experimental Medicine (IKEM) | Recruiting | Prague | 14059 | Czechia |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D020257 | Ventricular Remodeling |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| during the first 5 day after AMI |
| day 1, 2 and 5 |
| maximum hs-TnT, BNP, serum lactate | diference in hs-TnT, BNP and lactate between the groups | during the first 5 day after AMI |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
| D012769 | Shock |