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NCT06438315ClinicalTrials.gov

SuperSaturated Oxygen Comprehensive Observational Registry

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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.

Osservazionale1000 partecipanti ricercati25 centri1 paese

Categorie

Cardiovascolare100%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2024-05-31; recorded start 2024-08-13
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Whether the study is blinded is not stated in the registry recordNo masking information is recorded
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 2 other studies in this databaseCounted from the lead sponsor named in the record (TherOx)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Masking not stated in the record

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 25 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,000 participants (target), run at 25 sites.

How this score is built
  • Enrolment30/40

    1,000 participants (target)

  • Site count17/25

    25 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 56 months

  • Sponsor scale1/10

    TherOx has led 3 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Sintesi

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.

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.

Patologie

  • STEMI - ST Elevation Myocardial Infarction
  • AMI

Idoneità

SessoTutti
Età18 Years – 80 Years
Volontari saniNo
Metodo di campionamentoNON_PROBABILITY_SAMPLE

Popolazione dello studio

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.

Idoneità come riportata nel registro

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 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioOsservazionale
FaseNon indicato nella scheda del registro
AssegnazioneNon indicato nella scheda del registro
Modello di interventoNon indicato nella scheda del registro
Finalità principaleNon indicato nella scheda del registro
MascheramentoNon indicato nella scheda del registro
Arruolamento1000 partecipanti ricercati

Sponsor e collaboratori

  • TherOx Sponsor

Bracci e interventi

  • SuperSaturated Oxygen (SSO2) Therapy

    Treated with SSO2

  • Control

    Not treated with SSO2

Interventi

  • Altro Eq5D

    Eq5d quality of life questionnaire

  • Altro KCCQ

    Quality of life questionnaire

  • Altro cMRI (Subset of patients)

    cardiac MRI

Esiti misurati

  1. Esito primario

    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.

    Orizzonte temporale Median of 1.5years

  2. Esito primario

    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.

    Orizzonte temporale 2-7 days after PCI

  3. Esito secondario

    MVO

    Microvascular obstruction (MVO) measured within 2-7 days post PCI

    Orizzonte temporale 2-7 days post PCI

  4. Esito secondario

    IMH

    Intramyocardial hemorrhage measured within 2-7 days post PCI

    Orizzonte temporale 2-7 days post PCI

  5. Esito secondario

    Rate of all cause mortality

    Rate of all cause mortality

    Orizzonte temporale 2 years

  6. Esito secondario

    Rate of cardiovascular death

    Rate of cardiovascular death

    Orizzonte temporale 2 years

  7. Esito secondario

    Rate of Hospitalization for Heart Failure

    Rate of Hospitalization for Heart Failure

    Orizzonte temporale 2 years

  8. Esito secondario

    Rate of All-cause Hospitalization

    Rate of All-cause Hospitalization

    Orizzonte temporale 2 years

  9. Esito secondario

    Change in EQ5D-3L Score

    Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health

    Orizzonte temporale 2 years

  10. Esito secondario

    Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Score

    Heart related patient reported outcome, scaled from 0 to 100, with 0 representing the worst symptoms and function and 100 representing the best

    Orizzonte temporale 2 years

Date

Data di inizio13 agosto 2024 (effettiva)
Conclusione primaria1 marzo 2027 (stimata)
Conclusione31 marzo 2029 (stimata)
Prima pubblicazione31 maggio 2024 (effettiva)
Ultimo aggiornamento20 agosto 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltamarzo 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

25 centri stanno reclutando

United States

StrutturaCittàStato o regioneStato
Charleston Area Medical CenterCharlestonWest VirginiaIn reclutamento
University of ChicagoChicagoIllinoisIn reclutamento
Mercy HospitalCoon RapidsMinnesotaIn reclutamento
Corewell Health Dearborn HospitalDearbornMichiganIn reclutamento
MemorialCare Orange Coast Medical CenterFountain ValleyCaliforniaIn reclutamento
St Mary's Medical CenterHuntingtonWest VirginiaIn reclutamento
RWJ- Jersey City Medical CenterJersey CityNew JerseyIn reclutamento
UCSD Health La Jolla - Sulpizio Cardiovascular CenterLa JollaCaliforniaIn reclutamento
MemorialCare Saddleback Medical CenterLaguna HillsCaliforniaIn reclutamento
MemorialCare Long Beach Medical CenterLong BeachCaliforniaIn reclutamento
Ronald Reagan UCLA Medical CenterLos AngelesCaliforniaIn reclutamento
North Shore University HospitalManhassetNew YorkIn reclutamento
Baptist Health Baptist HospitalMiamiFloridaIn reclutamento
Aurora St Luke's Medical CenterMilwaukeeWisconsinIn reclutamento
Abbott Northwestern HospitalMinneapolisMinnesotaIn reclutamento
NCH Baker HospitalNaplesFloridaIn reclutamento
NCH North NaplesNaplesFloridaIn reclutamento
Robert Wood Johnson University HospitalNew BrunswickNew JerseyIn reclutamento
Newark Beth Israel Medical CenterNewarkNew JerseyIn reclutamento
Carle Health Methodist HospitalPeoriaIllinoisIn reclutamento
Long Island Jewish HospitalQueensNew YorkIn reclutamento
United HospitalSaint PaulMinnesotaIn reclutamento
UCSD Hillcrest Medical CenterSan DiegoCaliforniaIn reclutamento
UCLA Santa Monica Medical CenterSanta MonicaCaliforniaIn reclutamento
Ascension Via Christi St FrancisWichitaKansasIn reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06438315