NCT05790876

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to demonstrate the improvement in Coronary Microcirculation Dysfunction (CMD) with Super Saturated Oxygene (SSO2) therapy in patients with anterior ST-segment Elevation Myocardial Infarction (STEMI) successfully revascularized by percutaneous coronary intervention (PCI). Participants will receive SSO2 therapy for 60 minutes, which aims to overoxygenate their blood. Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images.

Detailed description

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 catheter. Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images. Then, conventional follow-up of previous STEMI will be performed by imaging and functional assessment. The primary endpoint will be analyzed using a paired Student's t test, to take into account the evolution "before/after" implementation of SSO2 therapy on CMD. The demonstration of the beneficial effect of SSO2 therapy on CMD will allow the development of a care strategy based on CMD measurement by angio-IMR. Thus, this new treatment could be reserved for patients with severe CMD for which our management arsenal is still lacking, even though we know that CMD is a major prognostic factor in STEMI patients.

Conditions

• STEMI
• Coronary Microvascular Dysfunction

Interventions

Type	Name	Description
PROCEDURE	SSO2 therapy	SSO2 therapy consists of overoxygenating the patient's blood and delivering it to the origin of the LAD for 60 min. Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images

Timeline

• Start date: 2023-03-21
• Primary completion: 2025-03-07
• Completion: 2025-06-11
• First posted: 2023-03-30
• Last updated: 2025-06-17

Locations

1 site across 1 country: France