Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05949515
  4. Details
NCT05949515 Clinical Trial

Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility

Acute ST Segment Elevation Myocardial Infarction Clinical Trial

— RESCU  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05949515
Other study ID # RESCU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2023
Est. completion date March 31, 2024

Study information
Verified date April 2024
Source Cardiovascular Research Foundation, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 403
Est. completion date March 31, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States OhioHealth Research Institute Columbus Ohio
United States Oakwood Healthcare, Inc Dearborn Michigan
United States Avita Health Galion Ohio
United States Northwell Health, Inc Great Neck New York
United States St. Mary's Medical Center Huntington West Virginia
United States Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute Miami Florida
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States NCH Healthcare System Naples Florida

Sponsors (1)
Lead Sponsor Collaborator
Cardiovascular Research Foundation, New York

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Left Ventricular Ejection Fraction Between group comparison Baseline to 3 months
Primary Rate of Cardiovascular related Hospitalizations Between group comparison Through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Completed NCT02914795 - Platelet Function in Resuscitated Patients
Recruiting NCT00697021 - Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance Phase 3
Completed NCT02828683 - Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study N/A
Completed NCT01986803 - ABSORB STEMI: the TROFI II Study N/A
Active, not recruiting NCT01878344 - Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention Phase 3
Withdrawn NCT02048085 - Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis Phase 4
Completed NCT04463251 - Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction Phase 2
Active, not recruiting NCT02943954 - FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction N/A
Completed NCT02298088 - Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis Phase 3
Active, not recruiting NCT02067091 - Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct Phase 3
Completed NCT01787110 - An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction Phase 3
Recruiting NCT03137212 - Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time N/A
Not yet recruiting NCT05802667 - A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
Completed NCT04730778 - Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients