SuperSaturated Oxygen Comprehensive Observational Registry
Purpose
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.
Conditions
- STEMI - ST Elevation Myocardial Infarction
- AMI
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
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
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 investigational drug or device trial
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| SuperSaturated Oxygen (SSO2) Therapy | Treated with SSO2 |
|
| Control | Not treated with SSO2 |
|
Recruiting Locations
Fountain Valley 5350207, California 5332921 92708
La Jolla 5363943, California 5332921 92037
Laguna Hills 5364306, California 5332921 92653
Long Beach 5367929, California 5332921 90806
San Diego 5391811, California 5332921 92103
Miami 4164138, Florida 4155751 33176
Naples 4165565, Florida 4155751 34102
Naples 4165565, Florida 4155751 34110
Chicago 4887398, Illinois 4896861 60637
Peoria 4905687, Illinois 4896861 61636
Wichita 4281730, Kansas 4273857 67214
Dearborn 4990510, Michigan 5001836 48124
Coon Rapids 5022025, Minnesota 5037779 55433
Minneapolis 5037649, Minnesota 5037779 55407
John Meriwether
Saint Paul 5045360, Minnesota 5037779 55102
John Meriwether
New Brunswick 5101717, New Jersey 5101760 08901
Newark 5101798, New Jersey 5101760 07112
Manhasset 5125766, New York 5128638 11030
Rajiv Jauhar, MD
(516) 562-0100
Queens 5133273, New York 5128638 11040
Charleston 4801859, West Virginia 4826850 25304
Huntington 4809537, West Virginia 4826850 25702
Cheryl Kane
Milwaukee 5263045, Wisconsin 5279468 53215
More Details
- NCT ID
- NCT06438315
- Status
- Recruiting
- Sponsor
- TherOx