SuperSaturated Oxygen Comprehensive Observational Registry
NCT ID: NCT06438315
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2024-08-13
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
No intervention
No intervention
Control
Not treated with SSO2
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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TherOx
INDUSTRY
Responsible Party
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Principal Investigators
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William W O'Neill, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital
Locations
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MemorialCare Orange Coast Medical Center
Fountain Valley, California, United States
UCSD Health La Jolla - Sulpizio Cardiovascular Center
La Jolla, California, United States
MemorialCare Saddleback Medical Center
Laguna Hills, California, United States
MemorialCare Long Beach Medical Center
Long Beach, California, United States
UCSD Hillcrest Medical Center
San Diego, California, United States
Baptist Health Baptist Hospital
Miami, Florida, United States
NCH Baker Hospital
Naples, Florida, United States
NCH North Naples
Naples, Florida, United States
University of Chicago
Chicago, Illinois, United States
Carle Health Methodist Hospital
Peoria, Illinois, United States
Ascension Via Christi St Francis
Wichita, Kansas, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Hospital
Queens, New York, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
St Mary's Medical Center
Huntington, West Virginia, United States
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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John Meriwether
Role: primary
John Meriwether
Role: primary
Rajiv Jauhar, MD
Role: primary
Cheryl Kane
Role: primary
References
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Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.
David SW, Khan ZA, Patel NC, Metzger DC, Wood FO, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2019 Apr 1;93(5):882-890. doi: 10.1002/ccd.27905. Epub 2018 Sep 28.
Other Identifiers
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EDC-5731
Identifier Type: -
Identifier Source: org_study_id
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