Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction
NCT ID: NCT05790876
Last Updated: 2025-06-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
15 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-03-21
Study Completion Date
2025-06-11
Brief Summary
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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.
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.
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Detailed Description
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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.
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
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STEMI
Coronary Microvascular Dysfunction
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Prospective, single-center, non-controlled, non-randomized, open-label study (pilot study)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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
Group Type
EXPERIMENTAL
SSO2 therapy
Intervention Type
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
Interventions
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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
Intervention Type
PROCEDURE
Eligibility Criteria
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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)
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Zoll Medical Corporation
INDUSTRY
Sponsor Role
collaborator
University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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University Hospital Grenoble
La Tronche, , France
Site Status
Countries
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France
References
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Other Identifiers
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2022-A02380-43
Identifier Type: OTHER
Identifier Source: secondary_id
38RC22.0268
Identifier Type: -
Identifier Source: org_study_id
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