SuperSaturated Oxygen Comprehensive Observational Registry

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое KCCQ
  Quality of life questionnaire
• Другое Eq5D
  Eq5d quality of life questionnaire
• Другое cMRI (Subset of patients)
  cardiac MRI

Первичные конечные точки

• Cardiovascular (CV) death or Heart Failure (HF) burden [Срок оценки: Median of 1.5years]
• Infarct Size [Срок оценки: 2-7 days after PCI]

Вторичные конечные точки (8)

• MVO [Срок оценки: 2-7 days post PCI]
• IMH [Срок оценки: 2-7 days post PCI]
• Rate of all cause mortality [Срок оценки: 2 years]
• Rate of cardiovascular death [Срок оценки: 2 years]
• Rate of Hospitalization for Heart Failure [Срок оценки: 2 years]
• Rate of All-cause Hospitalization [Срок оценки: 2 years]
• Change in EQ5D-3L Score [Срок оценки: 2 years]
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score [Срок оценки: 2 years]

Критерии участия

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 25 центров

• MemorialCare Orange Coast Medical Center — Fountain Valley
• UCSD Health La Jolla - Sulpizio Cardiovascular Center — La Jolla
• MemorialCare Saddleback Medical Center — Laguna Hills
• MemorialCare Long Beach Medical Center — Long Beach
• Ronald Reagan UCLA Medical Center — Los Angeles
• UCSD Hillcrest Medical Center — San Diego
• UCLA Santa Monica Medical Center — Santa Monica
• Baptist Health Baptist Hospital — Miami
• … и ещё 17 центров

Публикации

• 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/CIRCINTERVENTIO PMID 20031745
• 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. PMID 30265429

Идентификаторы

NCT: NCT06438315 · EDC-5731

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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