Registry evaluating SuperSaturated Oxygen Therapy for heart attack treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) is designed to assess the effectiveness of SuperSaturated Oxygen (SSO2) Therapy compared to standard percutaneous coronary intervention (PCI) in patients with anterior acute myocardial infarction (AMI). This observational study will collect real-world data on the impact of SSO2 Therapy on heart failure burden and healthcare resource utilization. By analyzing this data, the registry aims to provide insights into the clinical utility of SSO2 Therapy in routine practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• MemorialCare Orange Coast Medical Center
  Fountain Valley, California, United States Recruiting
• UCSD Health La Jolla - Sulpizio Cardiovascular Center
  La Jolla, California, United States Recruiting
• MemorialCare Saddleback Medical Center
  Laguna Hills, California, United States Recruiting
• MemorialCare Long Beach Medical Center
  Long Beach, California, United States Recruiting
• Ronald Reagan UCLA Medical Center
  Los Angeles, California, United States Recruiting
• UCSD Hillcrest Medical Center
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: William W O'Neill, MD — Henry Ford Hospital
• Study coordinator: Jennifer Gardner
• Email: sscore.zoll@zoll.com
• Phone: 949-300-2811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Prehospital pulse-dose methylprednisolone for ST-elevation myocardial infarction

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• Epicardial fat CT in patients after heart attack

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.