SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE)

August 18, 2026 updated by: TherOx
The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility, infarct size reduction, and cost-effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of SSCORE is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall HF (heart failure) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. Additionally, the study will confirm infarct size reduction in patients treated with SSO2 Therapy compared to standard of care treatment. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • MemorialCare Orange Coast Medical Center
        • Principal Investigator:
          • Khiet Hoang, MD
        • Contact:
      • La Jolla, California, United States, 92037
        • Recruiting
        • UCSD Health La Jolla - Sulpizio Cardiovascular Center
        • Principal Investigator:
          • Lawrence Ang, MD
        • Contact:
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • MemorialCare Saddleback Medical Center
        • Principal Investigator:
          • Khiet Hoang, MD
        • Contact:
      • Long Beach, California, United States, 90806
        • Recruiting
        • MemorialCare Long Beach Medical Center
        • Principal Investigator:
          • Khiet Hoang, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Principal Investigator:
          • Rushi Parikh, MD
        • Contact:
      • San Diego, California, United States, 92103
        • Recruiting
        • UCSD Hillcrest Medical Center
        • Principal Investigator:
          • Lawrence Ang, MD
        • Contact:
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA Santa Monica Medical Center
        • Principal Investigator:
          • Rushi Parikh, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33176
      • Naples, Florida, United States, 34102
        • Recruiting
        • NCH Baker Hospital
        • Contact:
        • Principal Investigator:
          • Mazen Albaghdadi, MD
      • Naples, Florida, United States, 34110
        • Recruiting
        • NCH North Naples
        • Contact:
        • Principal Investigator:
          • Luis Paz Rios, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Carle Health Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Surya Chaturvedula, MD
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi St Francis
        • Principal Investigator:
          • Bassem Chehab, MD
        • Contact:
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Recruiting
        • Corewell Health Dearborn Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Chattahi, MD
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Jeff Chambers, MD
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Principal Investigator:
          • Jay Traverse, MD
        • Contact:
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Principal Investigator:
          • Jay Traverse, MD
        • Contact:
    • New Jersey
      • Jersey City, New Jersey, United States, 07302
        • Recruiting
        • RWJ- Jersey City Medical Center
        • Contact:
        • Principal Investigator:
          • Kim Skelding, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Hospital
        • Contact:
        • Principal Investigator:
          • Tudor Vagaonescu, MD
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
        • Principal Investigator:
          • Sergio Waxman, MD
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
          • Rajiv Jauhar, MD
          • Phone Number: (516) 562-0100
        • Principal Investigator:
          • Rajiv Jauhar, MD
      • Queens, New York, United States, 11040
        • Recruiting
        • Long Island Jewish Hospital
        • Contact:
        • Principal Investigator:
          • Rajiv Jauhar, MD
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • Charleston Area Medical Center
        • Contact:
        • Principal Investigator:
          • Elise Anderson, MD
      • Huntington, West Virginia, United States, 25702
        • Recruiting
        • St Mary's Medical Center
        • Principal Investigator:
          • Mehiar El-Hamdani, MD
        • Contact:
          • Cheryl Kane
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Fuad Jan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control
Not treated with SSO2
Other: KCCQ
Quality of life questionnaire
Other: Eq5D
Eq5d quality of life questionnaire
Other: cMRI (Subset of patients)
cardiac MRI
SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
Other: KCCQ
Quality of life questionnaire
Other: Eq5D
Eq5d quality of life questionnaire
Other: cMRI (Subset of patients)
cardiac MRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiovascular (CV) death or Heart Failure (HF) burden
Time Frame: Median of 1.5years
The clinical outcome will be a non-hierarchical composite measured during a median follow-up of 1.5 years (minimum of 1 year and maximum of 2 years). The composite will be analyzed as the time-to-first occurrence of CV death or HF event, defined as new/worsening HF requiring hospitalization or outpatient treatment.
Median of 1.5years
Infarct Size
Time Frame: 2-7 days after PCI
Cardiac magnetic resonance imaging will be used to measure the co-primary endpoint of infarct size within 2-7 days after PCI in a subset of patients.
2-7 days after PCI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of all cause mortality
Time Frame: 2 years
Rate of all cause mortality
2 years
Rate of All-cause Hospitalization
Time Frame: 2 years
Rate of All-cause Hospitalization
2 years
Rate of cardiovascular death
Time Frame: 2 years
Rate of cardiovascular death
2 years
Rate of Hospitalization for Heart Failure
Time Frame: 2 years
Rate of Hospitalization for Heart Failure
2 years
Change in EQ5D-3L Score
Time Frame: 2 years
Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health
2 years
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score
Time Frame: 2 years
Heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best
2 years
MVO
Time Frame: 2-7 days post PCI
Microvascular obstruction (MVO) measured within 2-7 days post PCI
2-7 days post PCI
IMH
Time Frame: 2-7 days post PCI
Intramyocardial hemorrhage measured within 2-7 days post PCI
2-7 days post PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TherOx

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William W O'Neill, MD, Henry Ford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EDC-5731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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