NCT05790876Completed
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 28 Feb 2023
- Start date
- 21 Mar 2023
- Primary completion date
- 7 Mar 2025
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Coronary artery disease
- NCT number
- NCT05790876
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 21 Mar 2023 to the primary completion date, 7 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myocardial infarction
- Use of thrombolytic therapy
- Patients with a contraindication to anticoagulant therapy.
- Gastrointestinal or urogenital bleeding within the last two months or any major surgery (including CABG) within six weeks prior to surgery.
Other illness
- History of anterior coronary artery bypass grafting (CABG)
- History of PCI on the LAD
- Valvular stenosis or heart failure, pericardial disease, or nonischemic cardiomyopathy.
Lab values
- Known prior left ventricular ejection fraction (LVEF) \< 40%,
- Creatinine clearance \<30 ml/min/1.73 m2,
- Hemoglobin \<10 g/dL
Age
- Female of childbearing age
Other
- 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.
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Grenoble Coordinator of this site? Confirm its status | La Tronche | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.