SuperSaturated Oxygen Comprehensive Observational Registry

Purpose

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.

Conditions

  • STEMI - ST Elevation Myocardial Infarction
  • AMI

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label or All Others) Cohorts must meet ALL the following baseline criteria: - Men or women aged 18 years or older - 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 tree - Successful primary PCI within 6 hours of symptom onset, 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 perforation, serious bleeding, or cardiogenic shock - 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 investigational drug or device trial

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
SuperSaturated Oxygen (SSO2) Therapy Treated with SSO2
  • Other: No intervention
    No intervention
Control Not treated with SSO2
  • Other: No intervention
    No intervention

Recruiting Locations

MemorialCare Orange Coast Medical Center
Fountain Valley 5350207, California 5332921 92708
Contact:
Shavelle, MD
714-378-7000
Research@memorialcare.org

UCSD Health La Jolla - Sulpizio Cardiovascular Center
La Jolla 5363943, California 5332921 92037
Contact:
Lawrence Ang, MD
858-657-8530
lang@health.ucsd.edu

MemorialCare Saddleback Medical Center
Laguna Hills 5364306, California 5332921 92653
Contact:
Shavelle, MD
949-452-7191
Research@memorialcare.org

MemorialCare Long Beach Medical Center
Long Beach 5367929, California 5332921 90806
Contact:
Shavelle, MD
562-933-3370
Research@memorialcare.org

UCSD Hillcrest Medical Center
San Diego 5391811, California 5332921 92103
Contact:
Lawrence Ang, MD
858-657-7000
lang@health.ucsd.edu

Baptist Health Baptist Hospital
Miami 4164138, Florida 4155751 33176
Contact:
Ramon Quesada, MD
(786) 596-1960
DG-MCVIResearchRegulatory@baptisthealth.net

NCH Baker Hospital
Naples 4165565, Florida 4155751 34102
Contact:
Mazen Albaghdadi, MD
2396245000
mazen.albaghdadi@nchmd.org

NCH North Naples
Naples 4165565, Florida 4155751 34110
Contact:
Mazen Albaghdadi, MD
(239) 624-5000
mazen.albaghdadi@nchmd.org

University of Chicago
Chicago 4887398, Illinois 4896861 60637
Contact:
Adam Vohra, MD
Adam.Vohra@uchicagomedicine.org

Carle Health Methodist Hospital
Peoria 4905687, Illinois 4896861 61636
Contact:
Surya Chaturvedula, MD
(309) 672-5522
research@carle.com

Ascension Via Christi St Francis
Wichita 4281730, Kansas 4273857 67214
Contact:
Bassem Chehab, MD
(316) 268-5000
research@ascension.org

Corewell Health Dearborn Hospital
Dearborn 4990510, Michigan 5001836 48124
Contact:
Joseph Chattahi, MD
(313) 593-7000
Joseph.Chattahi@corewellhealth.org

Mercy Hospital
Coon Rapids 5022025, Minnesota 5037779 55433
Contact:
Jeff Chambers, MD
763-236-6000
J.Chambers@mhvi.com

Abbott Northwestern Hospital
Minneapolis 5037649, Minnesota 5037779 55407
Contact:
John Meriwether

United Hospital
Saint Paul 5045360, Minnesota 5037779 55102
Contact:
John Meriwether

Robert Wood Johnson University Hospital
New Brunswick 5101717, New Jersey 5101760 08901
Contact:
Tudor Vagaonescu, MD
(732) 828-3000
reasearch@rutgers.edu

Newark Beth Israel Medical Center
Newark 5101798, New Jersey 5101760 07112
Contact:
Sergio Waxman, MD
(973) 926-7000
sergio.waxman@rwjbh.org

North Shore University Hospital
Manhasset 5125766, New York 5128638 11030
Contact:
Rajiv Jauhar, MD
(516) 562-0100

Long Island Jewish Hospital
Queens 5133273, New York 5128638 11040
Contact:
Rajiv Jauhar, MD
718 470-7000
Rjauhar@northwell.edu

Charleston Area Medical Center
Charleston 4801859, West Virginia 4826850 25304
Contact:
Elise Anderson, MD
304-388-5432
zuser176@vandaliahealth.org

St Mary's Medical Center
Huntington 4809537, West Virginia 4826850 25702
Contact:
Cheryl Kane

Aurora St Luke's Medical Center
Milwaukee 5263045, Wisconsin 5279468 53215
Contact:
Fuad Jan, MD
(414) 649-6000
businessservices.research@aah.org

More Details

NCT ID
NCT06438315
Status
Recruiting
Sponsor
TherOx

Study Contact

Jennifer Gardner
949-300-2811
sscore.zoll@zoll.com