An observational study in Acute ST Segment Elevation Myocardial Infarction, sponsored by Cardiovascular Research Foundation, New York. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Cardiovascular Research Foundation, New York · Observational
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).
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.
688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.
This study's enrollment of 403 is above the median of 335 across 229 observational studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Cardiovascular Research Foundation, New York is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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Change of Left Ventricular Ejection Fraction
Between group comparison
Time frame: Baseline to 3 months
Rate of Cardiovascular related Hospitalizations
Between group comparison
Time frame: Through study completion, an average of 1 year
Ran from Jul 2023 to primary completion in Feb 2024, 6 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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ST Elevation Myocardial Infarction →
Cardiovascular Research Foundation, New York