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

Keywords

ClinConnect Summary

The PiCSO-STEMI trial is a clinical study designed to understand the effects of a new treatment called Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in patients who have had a severe heart attack known as anterior STEMI. The study will look at how PiCSO affects certain molecules in the body that could help us learn more about heart health, as well as how well blood is flowing in the small blood vessels of the heart. We want to see if this treatment leads to better outcomes for patients in terms of their heart function and quality of life, both right after the heart attack and up to a year later.

To participate in this trial, individuals need to be at least 18 years old and diagnosed with anterior STEMI, which is confirmed through specific heart tests. They should also be eligible for a procedure called primary PCI, a common treatment for heart attacks. However, there are some exclusions, like certain medical conditions or previous heart surgeries that may prevent someone from joining. If eligible, participants will receive either the PiCSO treatment or standard care during their hospital stay, and will be followed up over the next year to check on their recovery. This trial aims to provide valuable insights into how we can better treat and support patients after a heart attack.

Gender

ALL

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.