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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Left Ventricular Ejection Fraction | Between group comparison | Baseline to 3 months |
| Rate of Cardiovascular related Hospitalizations | Between group comparison | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
-
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute | Miami | Florida | 33176 | United States | ||
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| NCH Healthcare System |
| Naples |
| Florida |
| 34102 |
| United States |
| Oakwood Healthcare, Inc | Dearborn | Michigan | 48124 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Northwell Health, Inc | Great Neck | New York | 11021 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| Avita Health | Galion | Ohio | 44833 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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