NCT06438315Recruiting
SuperSaturated Oxygen Comprehensive Observational Registry
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 21 May 2024
- Start date
- 13 Aug 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- TherOx
- Diseases
- Coronary artery disease
- NCT number
- NCT06438315
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 13 Aug 2024 to the primary completion date, Mar 2027
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in an interventional drug or device trial
Other illness
- 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.
Other
- 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
- 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:
Criteria the registry did not label
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charleston Area Medical Center Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Mercy Hospital Coordinator of this site? Confirm its status | Coon Rapids | United States | Recruiting |
| Corewell Health Dearborn Hospital Coordinator of this site? Confirm its status | Dearborn | United States | Recruiting |
| MemorialCare - Orange Coast Medical Center Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| St. Mary's Medical Center Coordinator of this site? Confirm its status | Huntington | United States | Recruiting |
| RWJ- Jersey City Medical Center Coordinator of this site? Confirm its status | Jersey City | United States | Recruiting |
| MemorialCare Saddleback Medical Center Coordinator of this site? Confirm its status | Laguna Hills | United States | Recruiting |
| UCSD Health La Jolla - Sulpizio Cardiovascular Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| MemorialCare Long Beach Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Ronald Reagan UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| North Shore University Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Recruiting |
| Baptist Health Baptist Hospital Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Aurora St. Luke's Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Abbott-Northwestern Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| NCH Baker Hospital Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| NCH North Naples Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Newark Beth Israel Medical Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Recruiting |
| Carle Health Methodist Hospital Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Long Island Jewish Hospital Coordinator of this site? Confirm its status | Queens | United States | Recruiting |
| Corewell Health William Beaumont University Hospital Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| United Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| UCSD Hillcrest Medical Center Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| UCLA Santa Monica Medical Center Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Corewell Health Wayne Hospital Coordinator of this site? Confirm its status | Wayne | United States | Recruiting |
| Ascension Via Christi St. Francis Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.