Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Mar 16, 2023

Keywords

ClinConnect Summary

Ten patients with acute anterior STEMI undergoing primary PCI will be enrolled. After successful PCI of a proximal lesion or middle left anterior descending artery (LAD), the patient will be informed and emergency consent will be obtained.

SSO2 therapy will then be performed. Blood is drawn from a femoral artery sheath and circulated via a roller pump through an extracorporeal oxygenator located in a polycarbonate chamber to achieve a PaO2 of 760 to 1000 mmHg. The overoxygenated blood is then delivered to the origin of the LAD at a flow rate of 100 ml/min for 60 minutes via a dedicated cat...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 years and \<80 years
• • ST-segment elevation myocardial infarction within 6 hours of symptom onset with ≥1 mm ST-segment elevation in ≥2 contiguous leads in V1-V4 or new left bundle branch block.
• • Successful PCI of a proximal or medial LAD lesion with commercially available coronary stents and achievement of residual stenosis \<50% diameter and thrombolysis-in-myocardial-infarction (TIMI) flow grade 2 or 3.
• • Systemic arterial pO2 greater than or equal to 10.7 kPa or 80 mmHg with or without oxygen supplementation.
• • Patient enrolled in a social security plan or beneficiary of such a plan
• • Consent obtained from the patient before inclusion (Emergency consent)
• Exclusion Criteria:
• • History of anterior coronary artery bypass grafting (CABG)
• • Previous myocardial infarction
• • History of PCI on the LAD
• • New LAD PCI planned within 30 days.
• • Mechanical complications of STEMI (Patients with ventricular pseudoaneurysm, ventricular septal defect (VSD), or severe mitral valve regurgitation (with or without papillary muscle rupture)), cardiogenic shock, or Presence of an intra-aortic counterpulsation balloon.
• • Valvular stenosis or heart failure, pericardial disease, or nonischemic cardiomyopathy.
• • Known prior left ventricular ejection fraction (LVEF) \< 40%,
• • Use of thrombolytic therapy
• • Patients with a contraindication to anticoagulant therapy.
• • Creatinine clearance \<30 ml/min/1.73 m2,
• • Hemoglobin \<10 g/dL
• • Gastrointestinal or urogenital bleeding within the last two months or any major surgery (including CABG) within six weeks prior to surgery.
• • Female of childbearing age
• • Patient on deferral or participating in another clinical investigation,
• • Protected populations: pregnant women, parturients, nursing mothers; persons deprived of liberty by a judicial or administrative decision; protected adults