Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility (RESCU)

April 3, 2024 updated by: Cardiovascular Research Foundation, New York

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)

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute
      • Naples, Florida, United States, 34102
        • NCH Healthcare System
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Oakwood Healthcare, Inc
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health, Inc
    • Ohio
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research Institute
      • Galion, Ohio, United States, 44833
        • Avita Health
    • West Virginia
      • Huntington, West Virginia, United States, 25702
        • St. Mary's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Minneapolis Heart Institute
The Feinstein Institutes for Medical Research
NCH Baker Downtown Hospital
OhioHealth Research Institute
Baptist Health Baptist Hospital
St. Mary's Medical Center
Corewell Health William Beaumont University Hospital - Research Institute
University of Chicago Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Left Ventricular Ejection Fraction
Time Frame: Baseline to 3 months
Between group comparison
Baseline to 3 months
Rate of Cardiovascular related Hospitalizations
Time Frame: Through study completion, an average of 1 year
Between group comparison
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Research Foundation, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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