Acute ST Segment Elevation Myocardial InfarctionRESCUNCT05949515
Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility
An observational study of Acute ST Segment Elevation Myocardial Infarction, run by Cardiovascular Research Foundation, New York at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction
- How many people
- 403 participants
- Where
- 8 sitesUnited States
- Study dates
- 31 Jul 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
OhioHealth Research Institute
Columbus, Ohio, 43214
Oakwood Healthcare, Inc
Dearborn, Michigan, 48124
Avita Health
Galion, Ohio, 44833
Northwell Health, Inc
Great Neck, New York, 11021
St. Mary's Medical Center
Huntington, West Virginia, 25702
Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute
Miami, Florida, 33176
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
NCH Healthcare System
Naples, Florida, 34102
About this study
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)
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).
Read the 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.
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Minneapolis Heart Institute | Not described | |
| The Feinstein Institutes for Medical Research | Not described | |
| NCH Baker Downtown Hospital | Not described | |
| OhioHealth Research Institute | Not described | |
| Baptist Health Baptist Hospital | Not described | |
| St. Mary's Medical Center | Not described | |
| Corewell Health William Beaumont University Hospital - Research Institute | Not described | |
| University of Chicago Medicine | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Left Ventricular Ejection Fraction
Between group comparison
Measured: Baseline to 3 months
Rate of Cardiovascular related Hospitalizations
Between group comparison
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start31 Jul 2023
- Primary completion28 Feb 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Research Foundation, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949515
- Sponsor's protocol ID
- RESCU
- Acronym
- RESCU
- Status last verified
- Apr 2024
- First submitted
- 28 Jun 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05949515
- Acronym / sponsor ID
- RESCU / RESCU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Cardiovascular Research Foundation, New YorkUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute ST Segment Elevation Myocardial Infarction, run by Cardiovascular Research Foundation, New York at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Left Ventricular Ejection Fraction (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.