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

NCT05790876 | Completed

• 2 other identifiers: 38RC22.02682022-A02380-43
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

STEMI; Coronary Microvascular Dysfunction

Keywords

STEMI; coronary microcirculatory dysfunction; SSO2 therapy

Outcome Measures

Primary Outcomes (1)

• Angio-IMR measurement before and after treatment with SSO2 therapy

  Angio-IMR measurement before and after treatment with SSO2 therapy to demonstrate improvement in CMD with SSO2 therapy in patients with anterior STEMI successfully revascularized by PCI

  Maximum 7 hours after symptoms

Secondary Outcomes (4)

• 30-day composite rate of net clinical adverse events (death, reinfarction, target vessel revascularization, stent thrombosis, severe heart failure or major/minor bleeding TIMI classification

  30 days

• Measurement of exercise performance

  3 months

• Reversal of cardiac remodeling

  Baseline and 3 months

• Late gadolinium enhancement by cardiac MRI to measure the infarct size

  3 months

Study Arms (1)

SSO2 therapy

EXPERIMENTAL

After successful PCI of a proximal or middle LAD lesion, the patient will be informed and emergency consent will be obtained. SSO2 therapy will then be performed. Overoxygenated blood will be delivered to the origin of the LAD for 60 minutes. Improvement in CMD will be assessed by comparing angio-IMR before and after 60 minutes of SSO2 therapy measured on conventional angiographic images

Procedure: SSO2 therapy

Interventions

SSO2 therapy PROCEDURE

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

SSO2 therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Zoll Medical Corporation: collaborator

Study Sites (1)

University Hospital Grenoble

La Tronche, 38700, France

Location

Related Publications (21)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, non-controlled, non-randomized, open-label study (pilot study)

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 30, 2023
• Study Start: March 21, 2023
• Primary Completion: March 7, 2025
• Study Completion: June 11, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

FR (1)