SuperSaturated Oxygen Comprehensive Observational Registry

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— SSCORE  

Official title:

SuperSaturated Oxygen Comprehensive Observational Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438315
• Other study ID #: EDC-5731
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: March 31, 2029

Study information

• Verified date: June 2024
• Source: TherOx
• Contact: Jennifer Gardner
• Phone: 949-300-2811
• Email: jgardner[@]zoll.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 31, 2029
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AMI
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TherOx

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular (CV) death or Heart Failure (HF) burden at 1 year	Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF	1 year
Secondary	Time to Cardiovascular (CV) death or HF burden	Days to the composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF	2 years
Secondary	Rate of all cause mortality	Rate of all cause mortality	2 years
Secondary	Rate of All-cause Hospitalization	Rate of All-cause Hospitalization	2 years
Secondary	Rate of cardiovascular death	Rate of cardiovascular death	2 years
Secondary	Rate of Hospitalization for Heart Failure	Rate of Hospitalization for Heart Failure	2 years
Secondary	Major Adverse Cardiovascular Events (MACE)	composite of rates of CV death, reinfarction, or HF hospitalization	2 years
Secondary	Rate of Reinfarction	Rate of Reinfarction	2 years
Secondary	Change in EQ5D-3L Score	Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health	2 years
Secondary	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score	Heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best	2 years
Secondary	Change in % of Left ventricular ejection fraction (LVEF)	Rate of change of LVEF from baseline to time point	2 years
Secondary	Change in New York Heart Association (NYHA) classification scale, I-IV	Rate of change of NHYA classification from baseline to time point	2 years