Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an A… (NCT01630707) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack
United States20 participantsStarted 2012-08
Plain-language summary
The purpose of this study is to evaluate the feasibility of the delivery of SuperSaturated Oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA). The therapy will be delivered with a commercially available qualified SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the treatment of patients presenting with an anterior acute myocardial infarction (heart attack) ≤ six hours after symptom onset with successful reperfusion (via PCI).
Who can participate
Age range
18 Years – 80 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 and ≤80 years of age.
. AMI must be anterior.
. Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration.
. Signed Informed Consent.
. Subject agrees to all required follow-up procedures and visits.
. Negative pregnancy test for women of childbearing potential.
. PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent in the LAD.
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.
1Since this trial was studying whether intracoronary SSO2 therapy is even feasible to deliver during a heart attack — not yet whether it works — what do the results tell us about how safe and practical this approach actually was for patients?
2This trial specifically focused on anterior wall heart attacks, so how does that location affect whether SSO2 therapy might be relevant to my particular situation?
3Since this trial has already been completed, has the data been published anywhere, and what did doctors learn that might influence whether this approach could become a real treatment option?
4Given that this was a feasibility study, are there follow-up trials now testing whether SSO2 therapy actually improves heart muscle recovery, and would it be worth waiting to see those results before considering this kind of approach?
5How does intracoronary SSO2 therapy compare to the standard treatments I would receive right now for my heart attack, and is there any reason to think exploring this route would be better than sticking with what's already proven?
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
The Feasibility of Intracoronary Infusion of SSO2 Therapy
. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery.
Exclusion criteria
3. Prior CABG surgery.
4. Prior myocardial infarction, or known prior systolic dysfunction.
5. Thrombolytic therapy administered for this STEMI.
6. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment.
7. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
8. Subjects who have previously undergone angioplasty or stenting in the LAD.
9. Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation.