STEMI - ST Elevation Myocardial Infarction, AMI
Conditions
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.
Detailed description
The goal of SSCORE is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall HF (heart failure) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. Additionally, the study will confirm infarct size reduction in patients treated with SSO2 Therapy compared to standard of care treatment. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.
Interventions
OTHERKCCQ
Quality of life questionnaire
OTHEREq5D
Eq5d quality of life questionnaire
OTHERcMRI (Subset of patients)
cardiac MRI
Sponsors
TherOx
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular (CV) death or Heart Failure (HF) burden | Median of 1.5years | 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. |
| Infarct Size | 2-7 days after PCI | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MVO | 2-7 days post PCI | Microvascular obstruction (MVO) measured within 2-7 days post PCI |
| IMH | 2-7 days post PCI | Intramyocardial hemorrhage measured within 2-7 days post PCI |
| Rate of all cause mortality | 2 years | Rate of all cause mortality |
| Rate of cardiovascular death | 2 years | Rate of cardiovascular death |
| Rate of Hospitalization for Heart Failure | 2 years | Rate of Hospitalization for Heart Failure |
| Rate of All-cause Hospitalization | 2 years | Rate of All-cause Hospitalization |
| Change in EQ5D-3L Score | 2 years | Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score | 2 years | Heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best |
Countries
United States
Contacts
CONTACTJennifer Gardner
PRINCIPAL_INVESTIGATORWilliam W O'Neill, MD
Henry Ford Hospital
Outcome results
None listed