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

STEMI Clinical Trial

— IC-HOT-MICRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05790876
• Other study ID #: 38RC22.0268
• Secondary ID: 2022-A02380-43
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: June 21, 2024

Study information

• Verified date: December 2022
• Source: University Hospital, Grenoble
• Contact: Gilles Barone-Rochette, MD, PhD
• Phone: 33476765172
• Email: gbarone[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Microvascular Dysfunction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Grenoble	La Tronche

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Zoll Medical Corporation

Country where clinical trial is conducted

France, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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-day composite criterion rate	30 days
Secondary	Measurement of exercise performance	Number of watts per exercise test at the end of cardiovascular rehabilitation	3 months
Secondary	Reversal of cardiac remodeling	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
Secondary	Late gadolinium enhancement by cardiac MRI to measure the infarct size	Measurement of infarct size	3 months