Clinical trial NCT06438315: SuperSaturated Oxygen Comprehensive Observational Registry
Official title: SuperSaturated Oxygen Comprehensive Observational Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: STEMI - ST Elevation Myocardial Infarction
AMI
Lead sponsor: TherOx
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will aim to prospectively enroll 500 subjects not treated with SuperSaturated Oxygen (SSO2) Therapy (Prospective Control Cohort), 500 subjects who received SSO2 Therapy in accordance with the product label (SSO2 Treated On-Label) and any subjects that receive SSO2 at an institution that meet criteria inclusion/exclusion (IE) criteria.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular (CV) death or Heart Failure (HF) burden at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Time to Cardiovascular (CV) death or HF burden
timeFrame: 2 years
measure: Rate of all cause mortality
timeFrame: 2 years
measure: Rate of All-cause Hospitalization
timeFrame: 2 years
measure: Rate of cardiovascular death
timeFrame: 2 years
measure: Rate of Hospitalization for Heart Failure
timeFrame: 2 years
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 2 years
measure: Rate of Reinfarction
timeFrame: 2 years
measure: Change in EQ5D-3L Score
timeFrame: 2 years
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score
timeFrame: 2 years
measure: Change in % of Left ventricular ejection fraction (LVEF)
timeFrame: 2 years
measure: Change in New York Heart Association (NYHA) classification scale, I-IV
timeFrame: 2 years
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: MemorialCare Orange Coast Medical Center
state: California
city: La Jolla
country: United States
facility: UCSD Health La Jolla - Sulpizio Cardiovascular Center
state: California
city: Laguna Hills
country: United States
facility: MemorialCare Saddleback Medical Center
state: California
city: Long Beach
country: United States
facility: MemorialCare Long Beach Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Hillcrest Medical Center
state: California
city: Miami
country: United States
facility: Baptist Health Baptist Hospital
state: Florida
city: Naples
country: United States
facility: NCH Baker Hospital
state: Florida
city: Naples
country: United States
facility: NCH North Naples
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: Carle Health Methodist Hospital
state: Illinois
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Queens
country: United States
facility: Long Island Jewish Hospital
state: New York
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Huntington
country: United States
facility: St Mary's Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Henry Ford Hospital
name: William W O&#39;Neill, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.