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STEMI - ST Elevation Myocardial InfarctionSSCORENCT06438315

SuperSaturated Oxygen Comprehensive Observational Registry

An observational study of STEMI - ST Elevation Myocardial Infarction and AMI, run by TherOx at 25 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
KCCQ, Eq5D and cMRI (Subset of patients)
How many people
1,000 participants
Where
25 sitesUnited States
Study dates
13 Aug 2024to 31 Mar 2029
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer Gardner contact

949-300-2811

sscore.zoll@zoll.com

25 sites in 1 country

United States25 sites, 25 recruiting

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

    Elise Anderson, MD, 304-388-5432, zuser176@vandaliahealth.org

    Elise Anderson, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Adam Vohra, MD, Adam.Vohra@uchicagomedicine.org

    Adam Vohra, MD

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Jeff Chambers, MD, 763-236-6000, J.Chambers@mhvi.com

    Jeff Chambers, MD

    Recruiting

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

    Joseph Chattahi, MD, (313) 593-7000, Joseph.Chattahi@corewellhealth.org

    Joseph Chattahi, MD

    Recruiting

  • MemorialCare Orange Coast Medical Center

    Fountain Valley, California, 92708

    Khiet Hoang, MD, 657-241-9051, Research@memorialcare.org

    Khiet Hoang, MD

    Recruiting

  • St Mary's Medical Center

    Huntington, West Virginia, 25702

    Cheryl Kane

    Mehiar El-Hamdani, MD

    Recruiting

  • RWJ- Jersey City Medical Center

    Jersey City, New Jersey, 07302

    Kim Skelding, MD, (201) 915-2000, Kimberly.Skelding@rwjbh.org

    Kim Skelding, MD

    Recruiting

  • UCSD Health La Jolla - Sulpizio Cardiovascular Center

    La Jolla, California, 92037

    Lawrence Ang, MD, 858-657-8530, lang@health.ucsd.edu

    Lawrence Ang, MD

    Recruiting

  • MemorialCare Saddleback Medical Center

    Laguna Hills, California, 92653

    Khiet Hoang, MD, 657-241-9051, Research@memorialcare.org

    Khiet Hoang, MD

    Recruiting

  • MemorialCare Long Beach Medical Center

    Long Beach, California, 90806

    Khiet Hoang, MD, 657-241-9051, Research@memorialcare.org

    Khiet Hoang, MD

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Regulatory Coordinator, (310) 825-9111, LDouangvila@mednet.ucla.edu

    Rushi Parikh, MD

    Recruiting

  • North Shore University Hospital

    Manhasset, New York, 11030

    Rajiv Jauhar, MD, (516) 562-0100

    Rajiv Jauhar, MD

    Recruiting

  • Baptist Health Baptist Hospital

    Miami, Florida, 33176

    Marcus St John, MD, (786) 596-1960, DG-MCVIResearchRegulatory@baptisthealth.net

    Marcus St John, MD

    Recruiting

  • Aurora St Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Fuad Jan, MD, (414) 649-6000, businessservices.research@aah.org

    Fuad Jan, MD

    Recruiting

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Colleen Quinlan, (612) 863-4000, Colleen.Quinlan@Allina.com

    Jay Traverse, MD

    Recruiting

  • NCH Baker Hospital

    Naples, Florida, 34102

    Mazen Albaghdadi, MD, 2396245000, mazen.albaghdadi@nchmd.org

    Mazen Albaghdadi, MD

    Recruiting

  • NCH North Naples

    Naples, Florida, 34110

    Luis Paz Rios, MD, (239) 624-5000, research@nchmed.org

    Luis Paz Rios, MD

    Recruiting

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

    Tudor Vagaonescu, MD, (732) 828-3000, reasearch@rutgers.edu

    Tudor Vagaonescu, MD

    Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Sergio Waxman, MD, (973) 926-7000, sergio.waxman@rwjbh.org

    Sergio Waxman, MD

    Recruiting

  • Carle Health Methodist Hospital

    Peoria, Illinois, 61636

    Surya Chaturvedula, MD, (309) 672-5522, research@carle.com

    Surya Chaturvedula, MD

    Recruiting

  • Long Island Jewish Hospital

    Queens, New York, 11040

    Rajiv Jauhar, MD, 718 470-7000, Rjauhar@northwell.edu

    Rajiv Jauhar, MD

    Recruiting

  • United Hospital

    Saint Paul, Minnesota, 55102

    Research Manager, (612) 863-4000, Colleen.Quinlan@Allina.com

    Jay Traverse, MD

    Recruiting

  • UCSD Hillcrest Medical Center

    San Diego, California, 92103

    Lawrence Ang, MD, 858-657-7000, lang@health.ucsd.edu

    Lawrence Ang, MD

    Recruiting

  • UCLA Santa Monica Medical Center

    Santa Monica, California, 90404

    Ladda Douangvila, (310) 825-9111, LDouangvila@mednet.ucla.edu

    Rushi Parikh, MD

    Recruiting

  • Ascension Via Christi St Francis

    Wichita, Kansas, 67214

    Bassem Chehab, MD, (316) 268-5000, research@ascension.org

    Bassem Chehab, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
KCCQ, Eq5D, cMRI (Subset of patients)
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KCCQOther

    Quality of life questionnaire

  • Eq5DOther

    Eq5d quality of life questionnaire

  • cMRI (Subset of patients)Other

    cardiac MRI

Study groups in NCT06438315
Study groupRoleWhat they receive
SuperSaturated Oxygen (SSO2) TherapyTreated with SSO2
Receives: Other: KCCQ; Other: Eq5D; Other: cMRI (Subset of patients)
ControlNot treated with SSO2
Receives: Other: KCCQ; Other: Eq5D; Other: cMRI (Subset of patients)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular (CV) death or Heart Failure (HF) burden

    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.

    Measured: Median of 1.5years

  2. Infarct Size

    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.

    Measured: 2-7 days after PCI

Secondary outcomes (8)

  1. MVO

    Microvascular obstruction (MVO) measured within 2-7 days post PCI

    Measured: 2-7 days post PCI

  2. IMH

    Intramyocardial hemorrhage measured within 2-7 days post PCI

    Measured: 2-7 days post PCI

  3. Rate of all cause mortality

    Rate of all cause mortality

    Measured: 2 years

  4. Rate of cardiovascular death

    Rate of cardiovascular death

    Measured: 2 years

  5. Rate of Hospitalization for Heart Failure

    Rate of Hospitalization for Heart Failure

    Measured: 2 years

  6. Rate of All-cause Hospitalization

    Rate of All-cause Hospitalization

    Measured: 2 years

  7. Change in EQ5D-3L Score

    Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health

    Measured: 2 years

  8. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score

    Heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2024
  2. Study start13 Aug 2024
  3. Primary completionMar 2027 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06438315
Sponsor's protocol ID
EDC-5731
Acronym
SSCORE
Status last verified
Mar 2026
First submitted
21 May 2024
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.

    PubMed 20031745

  • David SW, Khan ZA, Patel NC, Metzger DC, Wood FO, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2019 Apr 1;93(5):882-890. doi: 10.1002/ccd.27905. Epub 2018 Sep 28.

    PubMed 30265429

Questions about this trial

What is this clinical trial studying?

An observational study of STEMI - ST Elevation Myocardial Infarction and AMI, run by TherOx at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Gardner (949-300-2811, sscore.zoll@zoll.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular (CV) death or Heart Failure (HF) burden (time frame: Median of 1.5years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06438315, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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