NCT06438315 SuperSaturated Oxygen Comprehensive Observational Registry
| NCT ID | NCT06438315 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TherOx |
| Condition | STEMI - ST Elevation Myocardial Infarction |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-08-13 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
William W O'Neill, MD
PRINCIPAL INVESTIGATOR
Henry Ford Hospital
Frequently Asked Questions
Who can join the NCT06438315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying STEMI - ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06438315 currently recruiting?
Yes, NCT06438315 is actively recruiting participants. Contact the research team at sscore.zoll@zoll.com for enrollment information.
Where is the NCT06438315 trial being conducted?
This trial is being conducted at Fountain Valley, United States, La Jolla, United States, Laguna Hills, United States, Long Beach, United States and 11 additional locations.
Who is sponsoring the NCT06438315 clinical trial?
NCT06438315 is sponsored by TherOx. The principal investigator is William W O'Neill, MD at Henry Ford Hospital. The trial plans to enroll 1,000 participants.