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Набира участници NCT06438315

SuperSaturated Oxygen Comprehensive Observational Registry

Заболявания: STEMI - ST Elevation Myocardial Infarction AMI

Спонсор: TherOx

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
No intervention
OTHER
Места на провеждане 24
САЩ (24)
Charleston Area Medical Center
Charleston , West Virginia
University of Chicago
Chicago , Illinois
Mercy Hospital
Coon Rapids , Minnesota
Corewell Health Dearborn Hospital
Dearborn , Michigan
MemorialCare Orange Coast Medical Center
Fountain Valley , California
St Mary's Medical Center
Huntington , West Virginia
RWJ- Jersey City Medical Center
Jersey City , New Jersey
UCSD Health La Jolla - Sulpizio Cardiovascular Center
La Jolla , California
MemorialCare Saddleback Medical Center
Laguna Hills , California
MemorialCare Long Beach Medical Center
Long Beach , California
Ronald Reagan UCLA Medical Center
Los Angeles , California
North Shore University Hospital
Manhasset , New York
Rajiv Jauhar, MD
Baptist Health Baptist Hospital
Miami , Florida
Aurora St Luke's Medical Center
Milwaukee , Wisconsin
Abbott Northwestern Hospital
Minneapolis , Minnesota
NCH Baker Hospital
Naples , Florida
NCH North Naples
Naples , Florida
Robert Wood Johnson University Hospital
New Brunswick , New Jersey
Newark Beth Israel Medical Center
Newark , New Jersey
Carle Health Methodist Hospital
Peoria , Illinois
Long Island Jewish Hospital
Queens , New York
United Hospital
Saint Paul , Minnesota
UCSD Hillcrest Medical Center
San Diego , California
Ascension Via Christi St Francis
Wichita , Kansas
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.08.2024
Крайна дата
31.03.2029
Регистрационен номер
NCT06438315
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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