1000 Participants Needed

SuperSaturated Oxygen Therapy for Heart Attack

(SSCORE Trial)

Recruiting at 21 trial locations
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Overseen ByJennifer Gardner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: TherOx
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of SuperSaturated Oxygen (SSO2) Therapy compared to the usual treatment for heart attacks, specifically those involving the heart's left front artery. The researchers aim to determine if SSO2 can reduce heart failure and healthcare costs more effectively than the standard procedure, percutaneous coronary intervention (PCI). Participants must have experienced a heart attack in the left front artery and received PCI treatment within 6 hours of symptom onset. This study will help determine if SSO2 Therapy offers additional benefits in real-world settings. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

What prior data suggests that SuperSaturated Oxygen (SSO2) Therapy is safe for patients with anterior acute myocardial infarction (AMI)?

Studies have shown that SuperSaturated Oxygen (SSO2) Therapy is generally safe for patients who have had heart attacks. Research indicates that SSO2 Therapy does not increase the risk of major heart problems compared to standard treatments. Nearly 800 patients participated in various studies, confirming its safety. This therapy has even been linked to better outcomes, such as fewer deaths and heart issues within a year after treatment. Overall, SSO2 Therapy appears promising with a good safety record for people recovering from heart attacks.12345

Why are researchers excited about this trial?

Researchers are excited about supersaturated oxygen (SSO2) therapy because it offers a unique approach to treating heart conditions, particularly following a heart attack. Unlike traditional treatments that mainly aim to restore blood flow and reduce clotting, SSO2 therapy works by delivering a higher concentration of oxygen directly to damaged heart tissue. This heightened oxygen delivery can potentially reduce tissue damage and improve heart function more effectively. By targeting the heart tissue in this novel way, SSO2 therapy might offer quicker recovery and better outcomes for patients compared to standard care options like medication and angioplasty.

What evidence suggests that SuperSaturated Oxygen Therapy is effective for acute myocardial infarction?

In this trial, participants will join one of two groups: one group will receive SuperSaturated Oxygen (SSO2) Therapy, while the other will serve as a control group and will not receive SSO2. Studies have shown that SSO2 Therapy can benefit individuals who have experienced heart attacks, particularly those affecting the front part of the heart. Research indicates that SSO2 Therapy reduces heart tissue damage after a heart attack. This therapy involves adding high levels of oxygen to the blood, aiding heart healing and potentially decreasing the risk of death and new heart problems. These findings suggest that SSO2 Therapy could be a promising option to improve recovery and reduce heart failure in heart attack patients.25678

Who Is on the Research Team?

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William W O'Neill, MD

Principal Investigator

Henry Ford Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I understand the study details and have signed the consent form.
My heart issue is mainly in the LAD coronary artery.
I am not pregnant or breastfeeding.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are observed and data is collected on the effectiveness of SSO2 Therapy versus PCI alone

1 year

Follow-up

Participants are monitored for cardiovascular outcomes and heart failure burden

2 years

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: SuperSaturated Oxygen (SSO2) TherapyExperimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

TherOx

Lead Sponsor

Trials
6
Recruited
1,900+

Citations

One‐year outcomes of supersaturated oxygen therapy in ...Infusion of SSO2 following pPCI in patients with anterior STEMI was associated with improved 1‐year clinical outcomes including lower rates of death and new‐ ...
Supersaturated oxygen therapy using radial artery access ...Health outcomes will include death, and cardiovascular events including MI heart failure, stroke/TIA and bleeding. Data on health outcomes will be collected ...
Supersaturated Oxygenation: Impact on Microvascular ...The efficacy in reducing infarct size has been attributed to the ability of SSO2 to achieve significantly higher levels of dissolved oxygen in ...
Intracoronary Infusion of Supersaturated Oxygen in ...Conclusions: Our findings demonstrate that SSO2 therapy may yield promising results by reducing infarct size in MI patients undergoing PCI.
Study Details | NCT06438315 | SuperSaturated Oxygen ...The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling. Official ...
TherOx DownStream System - accessdata.fda.govThe TherOx DownStream System, is indicated for the preparation and delivery of. SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions ...
SuperSaturated Oxygen Therapy for STEMIAMIHOT II met its prespecified safety endpoint of noninferiority for the composite of major adverse cardiovascular events at 30 days in the intention-to-treat ...
SuperSaturated Oxygen Therapy: Clinical OverviewTherOx has conducted several clinical studies to establish the safety and effectiveness of SSO2 Therapy. In total, nearly 800 patients have been clinically ...
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