Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction… (NCT05790876) | Clinical Trial Compass
CompletedNot Applicable
Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction
France15 participantsStarted 2023-03-21
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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)
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 ble…
What they're measuring
1
Angio-IMR measurement before and after treatment with SSO2 therapy