SuperSaturated Oxygen Comprehensive Observational Registry
SSCORE
1 other identifier
observational
1,000
1 country
24
Brief Summary
The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2024
CompletedFirst Posted
Study publicly available on registry
May 31, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
April 24, 2026
March 1, 2026
2.5 years
May 21, 2024
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Cardiovascular (CV) death or Heart Failure (HF) burden at 1 year
Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF
1 year
Secondary Outcomes (11)
Time to Cardiovascular (CV) death or HF burden
2 years
Rate of all cause mortality
2 years
Rate of All-cause Hospitalization
2 years
Rate of cardiovascular death
2 years
Rate of Hospitalization for Heart Failure
2 years
- +6 more secondary outcomes
Study Arms (2)
SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
Control
Not treated with SSO2
Interventions
Eligibility Criteria
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.
You may qualify if:
- Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label or All Others) Cohorts must meet ALL the following baseline criteria:
- Men or women aged 18 years or older
- 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 tree
- Successful primary PCI within 6 hours of symptom onset, 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 perforation, serious bleeding, or cardiogenic shock
- Not pregnant or nursing
You may not qualify if:
- 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 investigational drug or device trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TherOxlead
Study Sites (24)
MemorialCare Orange Coast Medical Center
Fountain Valley, California, 92708, United States
UCSD Health La Jolla - Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
MemorialCare Saddleback Medical Center
Laguna Hills, California, 92653, United States
MemorialCare Long Beach Medical Center
Long Beach, California, 90806, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCSD Hillcrest Medical Center
San Diego, California, 92103, United States
Baptist Health Baptist Hospital
Miami, Florida, 33176, United States
NCH Baker Hospital
Naples, Florida, 34102, United States
NCH North Naples
Naples, Florida, 34110, United States
University of Chicago
Chicago, Illinois, 60637, United States
Carle Health Methodist Hospital
Peoria, Illinois, 61636, United States
Ascension Via Christi St Francis
Wichita, Kansas, 67214, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
RWJ- Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Hospital
Queens, New York, 11040, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
St Mary's Medical Center
Huntington, West Virginia, 25702, United States
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (2)
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.
PMID: 20031745BACKGROUNDDavid 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.
PMID: 30265429BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William W O'Neill, MD
Henry Ford Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2024
First Posted
May 31, 2024
Study Start
August 13, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 31, 2029
Last Updated
April 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share