What is the mechanism of action of this treatment?

Common treatments for heart attacks, such as Supersaturated Oxygen (SSO2) Therapy, aim to increase oxygen delivery to ischemic myocardial tissue, thereby reducing the extent of myocardial injury. SSO2 therapy involves delivering highly oxygenated blood directly to the affected coronary artery, which helps to minimize tissue damage and improve recovery. This is crucial for heart attack patients as it can significantly reduce the size of the infarct, preserve heart function, and improve overall outcomes. Other treatments, like reperfusion therapy (e.g., angioplasty and thrombolytics), work by restoring blood flow to the blocked artery, further enhancing oxygen delivery and reducing ischemic damage.

What side effects are associated with this type of intervention?

Common treatments for heart attack that aim to increase oxygen delivery to ischemic myocardial tissue include thrombolytics, antiplatelet agents, anticoagulants, and percutaneous coronary intervention (PCI). Thrombolytics can cause significant bleeding, including intracranial hemorrhage. Antiplatelet agents like aspirin and P2Y12 inhibitors also increase bleeding risk. Anticoagulants such as heparin can lead to bleeding and heparin-induced thrombocytopenia. PCI may result in vascular injury, bleeding, and, in rare cases, stent thrombosis. Supersaturated Oxygen (SSO2) Therapy, being investigational, may have unique side effects related to oxygen toxicity or delivery mechanisms.

What prior FDA approvals exist?

FDA-approved treatments for heart attacks that focus on increasing oxygen delivery to ischemic myocardial tissue include thrombolytic agents like alteplase, which dissolve blood clots, and antiplatelet drugs such as aspirin and clopidogrel, which prevent further clot formation. Additionally, percutaneous coronary intervention (PCI) with stent placement is a common procedure to restore blood flow. While Supersaturated Oxygen (SSO2) Therapy is still under investigation, it aims to enhance oxygen delivery directly to the affected myocardial tissue, potentially offering a novel approach to myocardial salvage.

What other types of research exist?

Promising novel alternatives to Supersaturated Oxygen (SSO2) Therapy for heart attack patients include: 1) Inhaled nitric oxide (NO), which improves oxygenation and has shown benefits in pulmonary hypertension and myocardial ischemia. 2) Prostaglandin E2 (PGE2), which has shown potential in experimental models for reducing lung injury and could be beneficial in myocardial ischemia. 3) Oxygen free radical scavengers like superoxide dismutase and catalase, which may reduce oxidative stress and improve outcomes in ischemic conditions. 4) Phosphodiesterase-5 inhibitors (e.g., sildenafil), which can enhance vasodilation and improve blood flow to ischemic tissues.

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Supersaturated Oxygen Therapy for Cardiogenic Shock (ISO-SHOCK Trial)

N/A

Waitlist Available

Research Sponsored by TherOx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment that delivers very high levels of oxygen directly to the part of the heart affected by a severe heart attack. It targets patients who are in shock because their heart isn't pumping enough blood. The goal is to see if this extra oxygen can help their heart recover better.

Who is the study for?

Adults with a heart attack and shock, who have low blood pressure despite treatment or need drugs to keep their blood pressure up. They must show signs of poor blood flow to organs, have specific heart function measurements, completed successful angioplasty for the heart attack within 6 hours of symptoms starting, and be able to receive SSO2 therapy. Exclusions include planned surgeries soon after enrollment, MRI contraindications like certain metal implants or claustrophobia, severe brain injury from lack of oxygen, recent stroke or major surgery history.

What is being tested?

The trial is testing if delivering supersaturated oxygen (SSO2) into the artery affected by a heart attack can help patients in shock. It's done alongside standard treatments like angioplasty with stenting and mechanical support using Impella devices. Patients are randomly chosen to either get this additional SSO2 therapy or not as part of their care.

What are the potential side effects?

Potential side effects may include reactions related to the infusion such as inflammation at the site where it's delivered into the artery. There could also be risks associated with increased oxygen levels in that area which aren't fully known yet due to the investigational nature of this treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All cause mortality at 30-days in the SSO2 group rate compared with the control group rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PCI+Impella plus SSO2Experimental Treatment2 Interventions

Patients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated post-procedure with an infusion of SSO2 Therapy for a duration of 60 minutes.

Group II: PCI+ImpellaActive Control1 Intervention

Patients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated with Standard of Care.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart attacks, such as Supersaturated Oxygen (SSO2) Therapy, aim to increase oxygen delivery to ischemic myocardial tissue, thereby reducing the extent of myocardial injury. SSO2 therapy involves delivering highly oxygenated blood directly to the affected coronary artery, which helps to minimize tissue damage and improve recovery. This is crucial for heart attack patients as it can significantly reduce the size of the infarct, preserve heart function, and improve overall outcomes. Other treatments, like reperfusion therapy (e.g., angioplasty and thrombolytics), work by restoring blood flow to the blocked artery, further enhancing oxygen delivery and reducing ischemic damage.

Reduction of infarct size by oxygen inhalation following acute coronary occlusion.Therapeutic Hypothermia for Cardioprotection in Acute Myocardial Infarction.Effects of inotropic drugs on mechanical function and oxygen balance in postischemic canine myocardium: comparison of dobutamine, epinephrine, amrinone, and calcium chloride.