NCT06438315ClinicalTrials.gov

SuperSaturated Oxygen Comprehensive Observational Registry

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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.

Beobachtend1.000 Teilnehmende gesucht25 Studienzentren1 Land

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT06438315Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert letzten Monat

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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.

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

Zusammenfassung

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.

Erkrankungen

STEMI - ST Elevation Myocardial Infarction
AMI

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – 80 Years
Gesunde Freiwillige	Nein
Stichprobenverfahren	NON_PROBABILITY_SAMPLE

Studienpopulation

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.

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Beobachtend
Phase	Im Registereintrag nicht angegeben
Zuteilung	Im Registereintrag nicht angegeben
Interventionsmodell	Im Registereintrag nicht angegeben
Primäres Ziel	Im Registereintrag nicht angegeben
Verblindung	Im Registereintrag nicht angegeben
Teilnahme	1.000 Teilnehmende gesucht

Sponsor und Mitwirkende

TherOx Sponsor

Studienarme und Interventionen

SuperSaturated Oxygen (SSO2) Therapy
Treated with SSO2
Control
Not treated with SSO2

Interventionen

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

Endpunkte

Primärer Endpunkt
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.
Zeitrahmen Median of 1.5years
Primärer Endpunkt
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.
Zeitrahmen 2-7 days after PCI
Sekundärer Endpunkt
MVO
Microvascular obstruction (MVO) measured within 2-7 days post PCI
Zeitrahmen 2-7 days post PCI
Sekundärer Endpunkt
IMH
Intramyocardial hemorrhage measured within 2-7 days post PCI
Zeitrahmen 2-7 days post PCI
Sekundärer Endpunkt
Rate of all cause mortality
Rate of all cause mortality
Zeitrahmen 2 years
Sekundärer Endpunkt
Rate of cardiovascular death
Rate of cardiovascular death
Zeitrahmen 2 years
Sekundärer Endpunkt
Rate of Hospitalization for Heart Failure
Rate of Hospitalization for Heart Failure
Zeitrahmen 2 years
Sekundärer Endpunkt
Rate of All-cause Hospitalization
Rate of All-cause Hospitalization
Zeitrahmen 2 years
Sekundärer Endpunkt
Change in EQ5D-3L Score
Patient reported outcome, 0 to1, where 0 is death and 1 is perfect health
Zeitrahmen 2 years
Sekundärer Endpunkt
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
Zeitrahmen 2 years

Daten

Daten
Startdatum	13. August 2024 (tatsächlich)
Primärer Abschluss	1. März 2027 (geschätzt)
Abschluss	31. März 2029 (geschätzt)
Erstveröffentlichung	31. Mai 2024 (tatsächlich)
Zuletzt aktualisiert	20. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	März 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

25 Studienzentren rekrutieren

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Charleston Area Medical Center	Charleston	West Virginia	Rekrutiert
University of Chicago	Chicago	Illinois	Rekrutiert
Mercy Hospital	Coon Rapids	Minnesota	Rekrutiert
Corewell Health Dearborn Hospital	Dearborn	Michigan	Rekrutiert
MemorialCare Orange Coast Medical Center	Fountain Valley	California	Rekrutiert
St Mary's Medical Center	Huntington	West Virginia	Rekrutiert
RWJ- Jersey City Medical Center	Jersey City	New Jersey	Rekrutiert
UCSD Health La Jolla - Sulpizio Cardiovascular Center	La Jolla	California	Rekrutiert
MemorialCare Saddleback Medical Center	Laguna Hills	California	Rekrutiert
MemorialCare Long Beach Medical Center	Long Beach	California	Rekrutiert
Ronald Reagan UCLA Medical Center	Los Angeles	California	Rekrutiert
North Shore University Hospital	Manhasset	New York	Rekrutiert
Baptist Health Baptist Hospital	Miami	Florida	Rekrutiert
Aurora St Luke's Medical Center	Milwaukee	Wisconsin	Rekrutiert
Abbott Northwestern Hospital	Minneapolis	Minnesota	Rekrutiert
NCH Baker Hospital	Naples	Florida	Rekrutiert
NCH North Naples	Naples	Florida	Rekrutiert
Robert Wood Johnson University Hospital	New Brunswick	New Jersey	Rekrutiert
Newark Beth Israel Medical Center	Newark	New Jersey	Rekrutiert
Carle Health Methodist Hospital	Peoria	Illinois	Rekrutiert
Long Island Jewish Hospital	Queens	New York	Rekrutiert
United Hospital	Saint Paul	Minnesota	Rekrutiert
UCSD Hillcrest Medical Center	San Diego	California	Rekrutiert
UCLA Santa Monica Medical Center	Santa Monica	California	Rekrutiert
Ascension Via Christi St Francis	Wichita	Kansas	Rekrutiert

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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