SuperSaturated Oxygen Comprehensive Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 45
- 主要终点
- Cardiovascular (CV) death or Heart Failure (HF) burden at 1 year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 exclusion criteria will be considered for the cMRI sub-study.
- •cMRI Inclusion Criteria
- •Subjects will be included in the cMRI sub-study must meet all these criteria:
- •Meet all the inclusion and exclusion criteria for the overall study
- •Consent during index hospitalization to participate in the main study
- •cMRI Exclusion Criteria
- •Subjects will be excluded from the sub-study if they are contraindicated to MRI, including any of the following:
- •Non-MRI compatible cardiac pacemaker or implantable defibrillator; Non-MRI compatible aneurysm clip or other metallic implants; Neural Stimulator (i.e., TENS unit); Any implanted or magnetically activated device (insulin pump); Any type of non-MRI compatible ear implant; Metal shavings in the orbits; Any indwelling metallic foreign body, shrapnel, or bullet; Any condition contraindicating MRI, including claustrophobia; Inability to follow breath-hold instructions or to maintain a breath-hold for >15 seconds; and Known hypersensitivity or contraindication to gadolinium contrast.
研究组 & 干预措施
Control
Not treated with SSO2
干预措施: KCCQ (Other)
Control
Not treated with SSO2
干预措施: Eq5D (Other)
Control
Not treated with SSO2
干预措施: cMRI (Subset of patients) (Other)
SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
干预措施: Eq5D (Other)
SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
干预措施: cMRI (Subset of patients) (Other)
SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
干预措施: KCCQ (Other)
结局指标
主要结局
Cardiovascular (CV) death or Heart Failure (HF) burden at 1 year
时间窗: 1 year
Rate of composite of CV death, new onset HF, any new inpatient or outpatient treatment for HF, or worsening of HF
Cardiovascular (CV) death or Heart Failure (HF) burden
时间窗: 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
时间窗: 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.
次要结局
- Time to Cardiovascular (CV) death or HF burden(2 years)
- Change in New York Heart Association (NYHA) classification scale, I-IV(2 years)
- Rate of All-cause Hospitalization(2 years)
- Rate of all cause mortality(2 years)
- Rate of Hospitalization for Heart Failure(2 years)
- Major Adverse Cardiovascular Events (MACE)(2 years)
- Change in EQ5D-3L Score(2 years)
- Rate of Reinfarction(2 years)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score(2 years)
- Rate of cardiovascular death(2 years)
- Change in % of Left ventricular ejection fraction (LVEF)(2 years)
- MVO(2-7 days post PCI)
- IMH(2-7 days post PCI)