SuperSaturated Oxygen Comprehensive Observational Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorTherOx
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
KCCQ
Other interventionQuality of life questionnaire
Eq5D
Other interventionEq5d quality of life questionnaire
cMRI (Subset of patients)
Other interventioncardiac MRI
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: SuperSaturated Oxygen (SSO2) Therapy3 interventions
Group B: Control3 interventions
Trial outcomes
Primary outcomes
1
Cardiovascular (CV) death or Heart Failure (HF) burden
The clinical outcome will be a non-hierarchical composite measured during a median follow-up of 1.5 years (minimum of 1 year and maximum of 2 years). The composite will be analyzed as the time-to-first occurrence of CV death or HF event, defined as new/worsening HF requiring hospitalization or outpatient treatment.
Time frame
Median of 1.5years2
Infarct Size
Cardiac magnetic resonance imaging will be used to measure the co-primary endpoint of infarct size within 2-7 days after PCI in a subset of patients.
Time frame
2-7 days after PCISecondary outcomes
1
MVO
Microvascular obstruction (MVO) measured within 2-7 days post PCI
Time frame
2-7 days post PCI2
IMH
Intramyocardial hemorrhage measured within 2-7 days post PCI
Time frame
2-7 days post PCI3
Rate of all cause mortality
Rate of all cause mortality
Time frame
2 years4
Rate of cardiovascular death
Rate of cardiovascular death
Time frame
2 years Source ClinicalTrials.gov