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SSO2 Therapy for Heart Attack

N/A
Recruiting
Led By James Blankenship, MD
Research Sponsored by TherOx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be ≥18 years of age
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
Must not have
Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI
Subject has received any organ transplant or is on a waiting list for any organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trialstudies a new therapy for heart attack patients that achieved successful reperfusion within 6 hours.

Who is the study for?
This trial is for adults over 18 who've had a specific type of heart attack (anterior AMI) and received successful reperfusion via PCI within 6 hours after symptoms start. They must consent to the study, be able to follow up, have certain blood oxygen levels, and not belong to vulnerable groups or have conditions that could affect participation.
What is being tested?
The trial tests if delivering supersaturated Oxygen therapy directly into the coronary artery for an hour after successful PCI improves outcomes in heart attack patients compared to standard care. It's randomized and involves multiple centers.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to increased oxygen levels in the coronary arteries or issues from catheter placement such as bleeding or vessel damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I had a successful angioplasty within 6 hours of my symptoms starting, without major complications.
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I need a stent for my heart's main artery blockage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a stent placed in my heart and it caused a heart attack.
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I have had an organ transplant or am waiting for one.
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I haven't had major surgery or serious bleeding in the last 2 months.
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I have a heart artery blockage over 50% in a major artery or its branch.
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I have had a heart imaging test showing severe complications after a heart attack.
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I have not had a stroke or temporary paralysis in the last 6 months, nor do I have any lasting nerve damage.
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I have had a brain tumor, aneurysm, abnormal blood vessel connection, or bleeding stroke.
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My kidney function is very low or I am on dialysis.
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I do not have active bleeding, a bleeding disorder, or refuse blood transfusions.
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My heart artery tear wasn't fixed with a stent and is moderately severe.
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I have had treatment for a blockage in my heart's main or side arteries.
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My heart attack was caused by a clot in or near a stent.
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I am in the hospital due to COVID-19.
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I have had coronary artery bypass surgery.
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I do not have severe heart valve problems or heart muscle disease.
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I have had a procedure to open a blocked artery in my heart.
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I experienced severe heart issues during a heart procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1-year rate of Net Adverse Clinical Events (NACE)
Secondary study objectives
Difference in infarct size between SSO2 Therapy and standard therapy in patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PCI with SSO2 therapyExperimental Treatment2 Interventions
AMI subjects treated with SSO2 Therapy following PCI with stenting
Group II: anterior AMI patients treated with PCI and stenting within 6 hoursActive Control1 Intervention
Control group receiving PCI with stenting alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCI
2016
Completed Phase 4
~13010

Find a Location

Who is running the clinical trial?

TherOxLead Sponsor
5 Previous Clinical Trials
1,423 Total Patients Enrolled
James Blankenship, MDPrincipal InvestigatorUniversity of New Mexico
Gregg Stone, MDStudy ChairMOUNT SINAI HOSPITAL
13 Previous Clinical Trials
4,965 Total Patients Enrolled

Media Library

PCI Clinical Trial Eligibility Overview. Trial Name: NCT04743245 — N/A
Heart Attack Research Study Groups: PCI with SSO2 therapy, anterior AMI patients treated with PCI and stenting within 6 hours
Heart Attack Clinical Trial 2023: PCI Highlights & Side Effects. Trial Name: NCT04743245 — N/A
PCI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743245 — N/A
~126 spots leftby Oct 2025
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