Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility

NCT ID: NCT05949515

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Acute ST Segment Elevation Myocardial Infarction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Minneapolis Heart Institute

No interventions assigned to this group

The Feinstein Institutes for Medical Research

No interventions assigned to this group

NCH Baker Downtown Hospital

No interventions assigned to this group

OhioHealth Research Institute

No interventions assigned to this group

Baptist Health Baptist Hospital

No interventions assigned to this group

St. Mary's Medical Center

No interventions assigned to this group

Corewell Health William Beaumont University Hospital - Research Institute

No interventions assigned to this group

University of Chicago Medicine

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiovascular Research Foundation, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute

Miami, Florida, United States

Site Status

NCH Healthcare System

Naples, Florida, United States

Site Status

Oakwood Healthcare, Inc

Dearborn, Michigan, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Northwell Health, Inc

Great Neck, New York, United States

Site Status

OhioHealth Research Institute

Columbus, Ohio, United States

Site Status

Avita Health

Galion, Ohio, United States

Site Status

St. Mary's Medical Center

Huntington, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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RESCU

Identifier Type: -

Identifier Source: org_study_id

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