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Lack of financial support for recruitment and follow-up activities.
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| Name | Class |
|---|---|
| Miracor Medical SA | INDUSTRY |
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In this study we pretend to determine the molecular (miRNAs expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of PiCSO compared to a standard PCI control group in patients with high-risk anterior STEMI. Then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. Also, we will evaluate the impact of PiCSO on the coronary microcirculation beyond the acute phase in the follow-up six months after STEMI. Finally, we will assess PiCSO influence on Heart Failure (HF) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the STEMI event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICSO+PCI | Experimental |
| |
| Standard PCI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PiCSO Impulse System | Device | The PiCSO Impulse System is intended to reduce infarct size by intermittently occluding the coronary sinus outflow in patients undergoing a percutaneous coronary interventional procedure for myocardial infarction and presenting with Thrombolysis in myocardial infarction (TIMI) flow of 0 or 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of PiCSO in reducing microvascular dysfunction | To determine the superiority of PiCSO in reducing the microvascular dysfunction (defined as microvascular resistance >500 WU) as compared to standard of care | After primary PCI at time 0 after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be randomized (1:1) to PiCSO group or standard PCI control group. Once randomized, PiCSO group patients will receive PiCSO therapy inside the catheterization laboratory.
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The subjects as well as the investigator performing the procedure will not be blind to the study treatment. An independent experienced cardiologist, who will be blinded to all clinical data; will analyze anonymized Cardiac Magnetic Resonance (CMR) images for unbiased endpoints assessment.
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| Percutaneous Coronary Intervention (PCI) | Procedure | Minimally invasive procedures used to open clogged coronary arteries |
|
| ID | Term |
|---|---|
| D056988 | Anterior Wall Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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