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

June 12, 2025 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSO2 therapy
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angio-IMR measurement before and after treatment with SSO2 therapy
Time Frame: Maximum 7 hours after symptoms
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 30 days
30-day composite criterion rate
30 days
Measurement of exercise performance
Time Frame: 3 months
Number of watts per exercise test at the end of cardiovascular rehabilitation
3 months
Reversal of cardiac remodeling
Time Frame: Baseline and 3 months
Baseline and 3-month echocardiography. Left Ventricle (LV) remodeling is defined as an increase ≥20% in LV end-diastolic volume at 3 months after infarction.
Baseline and 3 months
Late gadolinium enhancement by cardiac MRI to measure the infarct size
Time Frame: 3 months
Measurement of infarct size
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Zoll Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Actual)

March 7, 2025

Study Completion (Actual)

June 11, 2025

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC22.0268
  • 2022-A02380-43 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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