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New oxygen therapy may limit heart damage after attack

NCT ID NCT06438315

Disease control Sponsor: TherOx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tracks 1,000 heart attack patients to see if adding SuperSaturated Oxygen therapy to standard angioplasty reduces heart muscle damage and improves outcomes. Participants are adults aged 18-80 who had a specific type of heart attack. The goal is to learn if this extra treatment is worth the cost and helps prevent future heart failure or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will aim to prospectively enroll 500 subjects not treated with SuperSaturated Oxygen (SSO2) Therapy (Prospective Control Cohort), 500 subjects who received SSO2 Therapy in accordance with the product label (SSO2 Treated On-Label) and any subjects that receive SSO2 at an institution that meet criteria inclusion/exclusion (IE) criteria.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label) Cohorts must meet ALL the following baseline criteria: Patients must be ≥ 18 years and ≤ 80 years of age Presentation with AMI and successful revascularization of the infarct-related artery with PCI The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB) Treatment with SSO2 Therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. Any subject that is treated with SSO2 Therapy and meets the baseline criteria should be invited to participate in the study. Subjects who are in the Prospective Control Cohort as well as subjects enrolled in the SSO2 Treated On-Label Cohort must meet these additional criteria: The primary culprit lesion must be in the left anterior descending (LAD) coronary artery Successful primary PCI within 6 hours of symptom onset (defined as persistent symptoms that caused the patient to pursue medical care), as documented by \<50% diameter residual angiographic stenosis and Thrombolysis In Myocardial Infarction (TIMI) Grades 2 or 3 flow in the target vessel No major complications such as presence of post-PCI dissection or perforation, serious bleeding, presence of cardiogenic shock (including the use of intra-aortic balloon pump (IABP) or mechanical circulatory support (MCS)) before the end of PCI procedure Not pregnant or nursing Exclusion Criteria Subjects will be excluded if they meet any of the following criteria: Life expectancy of less than 2 years No access to medical records from either the index hospitalization or subsequent outpatient visits Currently participating in an interventional drug or device trial cMRI Sub-Study At qualifying sites that can perform cMRI scans, subjects who meet the following inclusion and exclusion criteria will be considered for the cMRI sub-study. cMRI Inclusion Criteria Subjects will be included in the cMRI sub-study must meet all these criteria: Meet all the inclusion and exclusion criteria for the overall study Consent during index hospitalization to participate in the main study cMRI Exclusion Criteria Subjects will be excluded from the sub-study if they are contraindicated to MRI, including any of the following: Non-MRI compatible cardiac pacemaker or implantable defibrillator; Non-MRI compatible aneurysm clip or other metallic implants; Neural Stimulator (i.e., TENS unit); Any implanted or magnetically activated device (insulin pump); Any type of non-MRI compatible ear implant; Metal shavings in the orbits; Any indwelling metallic foreign body, shrapnel, or bullet; Any condition contraindicating MRI, including claustrophobia; Inability to follow breath-hold instructions or to maintain a breath-hold for \>15 seconds; and Known hypersensitivity or contraindication to gadolinium contrast.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AMI Stemi - ST elevation myocardial infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Ascension Via Christi St Francis

    RECRUITING

    Wichita, Kansas, 67214, United States

    Contact Email: •••••@•••••

  • Aurora St Luke's Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Health Baptist Hospital

    RECRUITING

    Miami, Florida, 33176, United States

  • Carle Health Methodist Hospital

    RECRUITING

    Peoria, Illinois, 61636, United States

    Contact Email: •••••@•••••

  • Charleston Area Medical Center

    RECRUITING

    Charleston, West Virginia, 25304, United States

  • Corewell Health Dearborn Hospital

    RECRUITING

    Dearborn, Michigan, 48124, United States

  • Long Island Jewish Hospital

    RECRUITING

    Queens, New York, 11040, United States

  • MemorialCare Long Beach Medical Center

    RECRUITING

    Long Beach, California, 90806, United States

    Contact Email: •••••@•••••

  • MemorialCare Orange Coast Medical Center

    RECRUITING

    Fountain Valley, California, 92708, United States

    Contact Email: •••••@•••••

  • MemorialCare Saddleback Medical Center

    RECRUITING

    Laguna Hills, California, 92653, United States

    Contact Email: •••••@•••••

  • Mercy Hospital

    RECRUITING

    Coon Rapids, Minnesota, 55433, United States

  • NCH Baker Hospital

    RECRUITING

    Naples, Florida, 34102, United States

  • NCH North Naples

    RECRUITING

    Naples, Florida, 34110, United States

    Contact Email: •••••@•••••

  • Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • North Shore University Hospital

    RECRUITING

    Manhasset, New York, 11030, United States

  • RWJ- Jersey City Medical Center

    RECRUITING

    Jersey City, New Jersey, 07302, United States

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • St Mary's Medical Center

    RECRUITING

    Huntington, West Virginia, 25702, United States

  • UCLA Santa Monica Medical Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • UCSD Health La Jolla - Sulpizio Cardiovascular Center

    RECRUITING

    La Jolla, California, 92037, United States

  • UCSD Hillcrest Medical Center

    RECRUITING

    San Diego, California, 92103, United States

  • United Hospital

    RECRUITING

    Saint Paul, Minnesota, 55102, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

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