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NCT06438315Recruiting

SuperSaturated Oxygen Comprehensive Observational Registry

TherOx

Start Date

8/13/2024

Completion Date

3/31/2029

Summary

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility, infarct size reduction, and cost-effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice.

Detailed Description

The goal of SSCORE is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall HF (heart failure) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. Additionally, the study will confirm infarct size reduction in patients treated with SSO2 Therapy compared to standard of care treatment. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.

Eligibility Criteria

Age Range: 18 years to 80 years

Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label) Cohorts must meet ALL the following baseline criteria: Patients must be ≥ 18 years and ≤ 80 years of age Presentation with AMI and successful revascularization of the infarct-related artery with PCI The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB) Treatment with SSO2 Therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. Any subject that is treated with SSO2 Therapy and meets the baseline criteria should be invited to participate in the study. Subjects who are in the Prospective Control Cohort as well as subjects enrolled in the SSO2 Treated On-Label Cohort must meet these additional criteria: The primary culprit lesion must be in the left anterior descending (LAD) coronary artery Successful primary PCI within 6 hours of symptom onset (defined as persistent symptoms that caused the patient to pursue medical care), as documented by \<50% diameter residual angiographic stenosis and Thrombolysis In Myocardial Infarction (TIMI) Grades 2 or 3 flow in the target vessel No major complications such as presence of post-PCI dissection or perforation, serious bleeding, presence of cardiogenic shock (including the use of intra-aortic balloon pump (IABP) or mechanical circulatory support (MCS)) before the end of PCI procedure Not pregnant or nursing Exclusion Criteria Subjects will be excluded if they meet any of the following criteria: Life expectancy of less than 2 years No access to medical records from either the index hospitalization or subsequent outpatient visits Currently participating in an interventional drug or device trial cMRI Sub-Study At qualifying sites that can perform cMRI scans, subjects who meet the following inclusion and exclusion criteria will be considered for the cMRI sub-study. cMRI Inclusion Criteria Subjects will be included in the cMRI sub-study must meet all these criteria: Meet all the inclusion and exclusion criteria for the overall study Consent during index hospitalization to participate in the main study cMRI Exclusion Criteria Subjects will be excluded from the sub-study if they are contraindicated to MRI, including any of the following: Non-MRI compatible cardiac pacemaker or implantable defibrillator; Non-MRI compatible aneurysm clip or other metallic implants; Neural Stimulator (i.e., TENS unit); Any implanted or magnetically activated device (insulin pump); Any type of non-MRI compatible ear implant; Metal shavings in the orbits; Any indwelling metallic foreign body, shrapnel, or bullet; Any condition contraindicating MRI, including claustrophobia; Inability to follow breath-hold instructions or to maintain a breath-hold for \>15 seconds; and Known hypersensitivity or contraindication to gadolinium contrast.

Interventions

OTHER

KCCQ

OTHER

Eq5D

OTHER

cMRI (Subset of patients)

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Conditions

STEMI - ST Elevation Myocardial InfarctionAMI

Locations

MemorialCare Orange Coast Medical Center

Fountain Valley, California 92708

United States

UCSD Health La Jolla - Sulpizio Cardiovascular Center

La Jolla, California 92037

United States

MemorialCare Saddleback Medical Center

Laguna Hills, California 92653

United States

MemorialCare Long Beach Medical Center

Long Beach, California 90806

United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095

United States

UCSD Hillcrest Medical Center

San Diego, California 92103

United States

UCLA Santa Monica Medical Center

Santa Monica, California 90404

United States

Baptist Health Baptist Hospital

Miami, Florida 33176

United States

NCH Baker Hospital

Naples, Florida 34102

United States

NCH North Naples

Naples, Florida 34110

United States

University of Chicago

Chicago, Illinois 60637

United States

Carle Health Methodist Hospital

Peoria, Illinois 61636

United States

Ascension Via Christi St Francis

Wichita, Kansas 67214

United States

Corewell Health Dearborn Hospital

Dearborn, Michigan 48124

United States

Mercy Hospital

Coon Rapids, Minnesota 55433

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

United Hospital

Saint Paul, Minnesota 55102

United States

RWJ- Jersey City Medical Center

Jersey City, New Jersey 07302

United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey 08901

United States

Newark Beth Israel Medical Center

Newark, New Jersey 07112

United States

North Shore University Hospital

Manhasset, New York 11030

United States

Long Island Jewish Hospital

Queens, New York 11040

United States

Charleston Area Medical Center

Charleston, West Virginia 25304

United States

St Mary's Medical Center

Huntington, West Virginia 25702

United States

Aurora St Luke's Medical Center

Milwaukee, Wisconsin 53215

United States