Clinical trial NCT05949515: Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility
Official title: Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility (RESCU). An Analysis of Clinical Outcomes and Left Ventricular Recovery of STEMI Patients Treated With SSO2 Therapy After Primary Percutaneous Coronary Intervention (PPCI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute ST Segment Elevation Myocardial Infarction
Lead sponsor: Cardiovascular Research Foundation, New York
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.

Brief summary: The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).

Detailed description: The TherOx® Downstream® System, which is approved for use in the United States (US) by the Food and Drug Administration (FDA) under P170027. The TherOx® Downstream® System consists of three primary components. These include a hardware device called the TherOx Downstream System ("console"), a single-use disposable device called the TherOx Downstream Cartridge ("cartridge") and a 5 French, commercially available qualified SSO2 infusion coronary delivery catheter ("delivery catheter").

This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.

Eligibility criteria: Inclusion Criteria:

* Data from all patients who received SSO2 treatment and have completed a minimum of 3 months follow up will be collected at each participating center; there are no other exclusion criteria aside from date of treatment.

Exclusion Criteria:

-

Primary outcomes:
measure: Change of Left Ventricular Ejection Fraction
timeFrame: Baseline to 3 months
measure: Rate of Cardiovascular related Hospitalizations
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute
state: Florida
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
city: Dearborn
country: United States
facility: Oakwood Healthcare, Inc
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Great Neck
country: United States
facility: Northwell Health, Inc
state: New York
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Galion
country: United States
facility: Avita Health
state: Ohio
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
References: