Recruiting

Observational Study

Sponsor:

TherOx

Code:

NCT06438315

Conditions

STEMI - ST Elevation Myocardial Infarction

AMI

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KCCQ

Eq5D

cMRI (Subset of patients)

Study Details

Brief 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.

Conditions

STEMI - ST Elevation Myocardial Infarction

AMI

Study ID

NCT06438315

Start date

Aug 13, 2024

Status verified date

Mar, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

SuperSaturated Oxygen (SSO2) Therapy

Treated with SSO2

Control

Not treated with SSO2

Interventions

KCCQ

Quality of life questionnaire

Eq5D

Eq5d quality of life questionnaire

cMRI (Subset of patients)

cardiac MRI

Primary outcome measure

  • Cardiovascular (CV) death or Heart Failure (HF) burden [ Time Frame: Median of 1.5years ]
  • Infarct Size [ Time Frame: 2-7 days after PCI ]

Central Contacts and Locations

Central contacts

Locations

MemorialCare Orange Coast Medical Center

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Principal Investigator:

Khiet Hoang, MD

UCSD Health La Jolla - Sulpizio Cardiovascular Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Lawrence Ang, MD

MemorialCare Saddleback Medical Center

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Principal Investigator:

Khiet Hoang, MD

MemorialCare Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Principal Investigator:

Khiet Hoang, MD

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Rushi Parikh, MD

UCSD Hillcrest Medical Center

Recruiting

San Diego, California, United States, 92103

Contacts

Principal Investigator:

Lawrence Ang, MD

UCLA Santa Monica Medical Center

Recruiting

Santa Monica, California, United States, 90404

Contacts

Principal Investigator:

Rushi Parikh, MD

Baptist Health Baptist Hospital

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Marcus St John, MD

NCH Baker Hospital

Recruiting

Naples, Florida, United States, 34102

Contacts

Principal Investigator:

Mazen Albaghdadi, MD

NCH North Naples

Recruiting

Naples, Florida, United States, 34110

Contacts

Principal Investigator:

Luis Paz Rios, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Adam Vohra, MD

Carle Health Methodist Hospital

Recruiting

Peoria, Illinois, United States, 61636

Contacts

Surya Chaturvedula, MD

(309) 672-5522research@carle.com

Principal Investigator:

Surya Chaturvedula, MD

Ascension Via Christi St Francis

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Principal Investigator:

Bassem Chehab, MD

Corewell Health Dearborn Hospital

Recruiting

Dearborn, Michigan, United States, 48124

Contacts

Principal Investigator:

Joseph Chattahi, MD

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

Jeff Chambers, MD

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

Jay Traverse, MD

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

Jay Traverse, MD

RWJ- Jersey City Medical Center

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

Principal Investigator:

Kim Skelding, MD

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Principal Investigator:

Tudor Vagaonescu, MD

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Principal Investigator:

Sergio Waxman, MD

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

Contacts

Rajiv Jauhar, MD

(516) 562-0100

Principal Investigator:

Rajiv Jauhar, MD

Long Island Jewish Hospital

Recruiting

Queens, New York, United States, 11040

Contacts

Principal Investigator:

Rajiv Jauhar, MD

Charleston Area Medical Center

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Principal Investigator:

Elise Anderson, MD

St Mary's Medical Center

Recruiting

Huntington, West Virginia, United States, 25702

Principal Investigator:

Mehiar El-Hamdani, MD

Aurora St Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Fuad Jan, MD

More Information

Sponsor

TherOx

Last update posted

Aug 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by TherOx on 2026-08-20.