Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Com… (NCT04743245) | Clinical Trial Compass
TerminatedNot Applicable
Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.
Stopped: Sponsor
United States17 participantsStarted 2022-08-02
Plain-language summary
A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject must be ≥18 years of age.
. AMI must be anterior (ST-segment elevation \>1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block).
. The subject or 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) or Ethics Committee (EC).
. Subject and his/her physician agree to all required follow-up procedures and visits.
. Based on coronary anatomy, PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent (bare metal or drug-eluting, at operator discretion) in the LAD.
. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions in the LAD target vessel, including diagonal branches, may be treated if clinically indicated).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — does that mean there were safety concerns, or was it stopped for a different reason, and how should that affect my thinking about SSO2 therapy?
2The trial was testing a 60-minute supersaturated oxygen treatment delivered during stent placement for a front-wall heart attack — is that kind of add-on therapy something that's still being studied elsewhere, or is there an alternative way I might access it?
3Since this study was measuring 'Net Adverse Clinical Events' over a full year, does that mean we still don't have solid evidence about whether SSO2 therapy helps or causes harm compared to standard stenting alone?
4Given that this trial is no longer enrolling, what is the current standard of care for my type of heart attack, and is there another active clinical trial you'd recommend I consider instead?
5Would the fact that this trial was terminated change your recommendation about whether SSO2 therapy is something worth pursuing as part of my treatment, or should I focus entirely on the established standard approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Successful angioplasty is completed \<6 hrs from symptom onset, as documented by 30% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.
. Expected ability to place the SSO2 delivery catheter in the coronary ostium of the left main coronary system to deliver SSO2 Therapy with stable, coaxial alignment.
Exclusion criteria
. Prior CABG surgery.
. Prior myocardial infarction or known prior systolic dysfunction (e.g. due to cardiomyopathy); this criterion does not include left ventricular dysfunction induced by the acute MI.
. An elective surgical procedure is planned during the first 30 days post-enrollment.
. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
. Subjects who have previously undergone an angioplasty or stenting procedure in the left anterior descending coronary artery.
. Contraindication to MRI imaging, including any of the following:
. Non-MRI compatible cardiac pacemaker or implantable defibrillator;
. Non-MRI compatible aneurysm clip or other metallic implants;