Incorporating Supersaturated Oxygen in Shock (NCT04876040) | Clinical Trial Compass
WithdrawnNot Applicable
Incorporating Supersaturated Oxygen in Shock
Stopped: Lack of enrollment
United States0Started 2021-12-17
Plain-language summary
A multi-center, prospective randomized (1:1) pilot and feasibility study to evaluate the safety and feasibility of supersaturated oxygen (SSO2) therapy delivered for 60 minutes selectively into the culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock (STEMI-CS) treated using a shock protocol.
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 patient must be ≥18 years of age.
. Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI).
. Cardiogenic shock is defined by the presence of at least 2 of the below criteria:
. Patient had pulmonary artery catheters placed for hemodynamic monitoring for clinical reasons
. Patient is treated with mechanical circulatory support with an Impella CP.
. Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written or remote/electronic informed consent, approved by the appropriate Institutional Review Board (IRB).
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1This trial was withdrawn before completing enrollment — does that mean there's no useful safety or effectiveness data from it, and how should that affect our decision-making about supersaturated oxygen therapy for my condition?
2Since this study was specifically looking at supersaturated oxygen therapy in people with both cardiogenic shock and STEMI, are there any other active trials or published research on this approach that might be relevant to my situation?
3Given that this trial was withdrawn, what are the current standard-of-care treatments for cardiogenic shock complicating a STEMI that my care team would recommend instead?
4Because the trial's main goal was to measure 30-day all-cause mortality, what does that tell us about how serious the risks are in this situation, and how does supersaturated oxygen fit into the bigger picture of my treatment options right now?
5Are there any other research studies or registries involving supersaturated oxygen therapy that are still enrolling patients, and would it be worth discussing whether any of those might be appropriate for my care team to look into?
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.
What they're measuring
1
All cause mortality at 30-days in the SSO2 group rate compared with the control group rate
. Patient or legally authorized representative 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).
Exclusion criteria
. A surgical procedure is planned during the first 30 days post-enrollment.
. 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;
. Neural Stimulator (i.e., TENS unit);
. Any implanted or magnetically activated device (insulin pump);