Effects of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy on miRNAs Expression and Absolute Microvascular Resistance by Continuous Thermodilution in ST-segment Elevation Myocardial Infarction (STEMI) Patients: PiCSO-STEMI TRIAL

Launched by FUNDACIO PRIVADA MON CLINIC BARCELONA · Nov 30, 2022

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old.
• • 2. Anterior STEMI (ECG with persistent elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial leads (V2, V3, V4) in men or ≥ 1.5 mm (0.15 mV) in women.
• • 3. Culprit lesion in proximal or mid Left Anterior Descending Artery (LAD).
• • 4. Pre-PCI TIMI flow 0-1.
• • 5. Symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours.
• • 6. The patient is eligible for primary PCI.
• • 7. Informed consent received and signed for study enrollment.
• Exclusion Criteria:
• • 1. Contraindication to coronary angiogram or PCI.
• • 2. Implants or foreign bodies in the coronary sinus.
• • 3. Known allergies to polyurethanes, Polyethylene Terephthalate (PET) or stainless steel.
• • 4. Known pregnancy or breastfeeding.
• • 5. Known coagulopathy.
• • 6. Known severe kidney disease (eGFR \<=30 mL/min/1.73) and/or hemodialysis.
• • 7. Known large pericardial effusion or cardiac tamponade.
• • 8. Central hemodynamically relevant left-right shunt.
• • 9. Previous MI or Coronary Artery Bypass Graft (CABG).
• • 10. Previous history of stroke, transient ischemic attack (TIA) or reversible ischemic neurological deficit within last 6 months.
• • 11. Cardiopulmonary resuscitated (CPR) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present.
• • 12. Unconscious at presentation.
• • 13. Need for circulatory support.
• • 14. Need for invasive mechanical ventilation.
• • 15. Need for temporal intravenous pacemaker.
• • 16. Patient not suitable for femoral access.
• • 17. Known contraindication for adenosine administration (severe asthma, complicated Atrioventricular (AV) block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases).
• • 18. Known epicardial stenosis greater than 50% distal to the culprit LAD lesion.
• • 19. Active participation in another drug or device investigational trial.
• • 20. Medical, social or psychological condition that limits the ability of patient to participate in the study.
• • 21. Patients with definite or probable coronavirus disease 19 diagnosis within 2 weeks prior to STEMI.