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NCT06438315 · ClinicalTrials.gov registry record
SuperSaturated Oxygen Comprehensive Observational Registry
A clinical trial of STEMI - ST Elevation Myocardial Infarction and AMI, sponsored by TherOx.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 20
- Study locations
NCT06438315: Recruiting study of STEMI - ST Elevation Myocardial Infarction and AMI, sponsored by TherOx.
NCT06438315 is a study of STEMI - ST Elevation Myocardial Infarction and AMI that is actively recruiting participants, run by TherOx. The registered enrollment target is 1,000 participants. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06438315, a study of STEMI - ST Elevation Myocardial Infarction and AMI, is actively recruiting participants, sponsored by TherOx.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER No intervention
Study Locations (20)
California
- MemorialCare Orange Coast Medical Center - Fountain Valley
- UCSD Health La Jolla - Sulpizio Cardiovascular Center - La Jolla
- MemorialCare Saddleback Medical Center - Laguna Hills
- MemorialCare Long Beach Medical Center - Long Beach
- UCSD Hillcrest Medical Center - San Diego
Florida
- Baptist Health Baptist Hospital - Miami
- NCH Baker Hospital - Naples
- NCH North Naples - Naples
Minnesota
- Mercy Hospital - Coon Rapids
- Abbott Northwestern Hospital - Minneapolis
- United Hospital - Saint Paul
New Jersey
- RWJ- Jersey City Medical Center - Jersey City
- Robert Wood Johnson University Hospital - New Brunswick
- Newark Beth Israel Medical Center - Newark
Illinois
- University of Chicago - Chicago
- Carle Health Methodist Hospital - Peoria
New York
- North Shore University Hospital - Manhasset
- Long Island Jewish Hospital - Queens
Kansas
- Ascension Via Christi St Francis - Wichita
Michigan
- Corewell Health Dearborn Hospital - Dearborn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2029-03-31 |
What NCT06438315 shows while recruiting
NCT06438315 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with STEMI - ST Elevation Myocardial Infarction appearing as the primary indexed condition, and to 1 intervention - of which No intervention is the first listed.
NCT06438315 names 20 study sites across 8 states, led by California, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06438315 about?
NCT06438315 is a clinical study titled "SuperSaturated Oxygen Comprehensive Observational Registry". 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 an...
What is the current status of trial NCT06438315?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2024-08-13. Estimated completion is 2029-03-31.
What conditions does trial NCT06438315 study?
This clinical trial studies the following conditions: STEMI - ST Elevation Myocardial Infarction, AMI.
What interventions are being tested in trial NCT06438315?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT06438315?
This trial is sponsored by TherOx, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06438315 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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