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

Sponsor
Cardiovascular Research Foundation, New York (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05949515
Collaborator
(none)
120
Enrollment
5.8
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    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)
    Anticipated Study Start Date :
    Jul 7, 2023
    Anticipated Primary Completion Date :
    Oct 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Change of Left Ventricular Ejection Fraction [Baseline to 3 months]

      Between group comparison

    2. Rate of Cardiovascular related Hospitalizations [Through study completion, an average of 1 year]

      Between group comparison

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cardiovascular Research Foundation, New York

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cardiovascular Research Foundation, New York
    ClinicalTrials.gov Identifier:
    NCT05949515
    Other Study ID Numbers:
    • RESCU
    First Posted:
    Jul 18, 2023
    Last Update Posted:
    Jul 18, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    ST Elevation Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Jul 18, 2023