Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility

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).

Completed

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Key information

Conditions

Acute ST Segment Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute, Miami, Florida, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change of Left Ventricular Ejection Fraction

Time frame: Baseline to 3 months

Between group comparison
Rate of Cardiovascular related Hospitalizations

Time frame: Through study completion, an average of 1 year

Between group comparison

Sponsors and collaborators

Lead sponsor

Cardiovascular Research Foundation, New York

Other

Registry information

Official study 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)

Acronym: RESCU

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 18, 2023
Registry last updated: Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed