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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year rate of Net Adverse Clinical Events (NACE)
Secondary outcome measures
Difference in infarct size between SSO2 Therapy and standard therapy in patients
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
4 Previous Clinical Trials
1,167 Total Patients Enrolled
James Blankenship, MDPrincipal InvestigatorUniversity of New Mexico
Gregg Stone, MDStudy ChairMOUNT SINAI HOSPITAL
13 Previous Clinical Trials
5,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stent placed in my heart and it caused a heart attack.You have a blockage of more than 20% in the main artery of your heart.I have had a heart attack or known heart muscle weakness not caused by a recent heart attack.You have a low platelet count (less than 100,000 cells/mm3) or a high platelet count (more than 700,000 cells/mm3), or low hemoglobin (less than 10 g/dL).I have had an organ transplant or am waiting for one.I haven't had major surgery or serious bleeding in the last 2 months.I have a heart artery blockage over 50% in a major artery or its branch.I am 18 years old or older.My heart condition allows for a specific catheter placement for treatment.I am scheduled for surgery within 30 days after joining the study.I do not have any other serious illnesses or substance abuse issues that could affect my participation.I have had a heart imaging test showing severe complications after a heart attack.You had a specific type of heart attack called an anterior myocardial infarction.I had COVID-19 but have been symptom-free and back to my normal health for at least 8 weeks.I have not had a stroke or temporary paralysis in the last 6 months, nor do I have any lasting nerve damage.I have had a brain tumor, aneurysm, abnormal blood vessel connection, or bleeding stroke.My kidney function is very low or I am on dialysis.I do not have active bleeding, a bleeding disorder, or refuse blood transfusions.My heart's main artery has been stented.I had a successful angioplasty within 6 hours of my symptoms starting, without major complications.Your blood oxygen level is higher than 80 mmHg.My heart artery tear wasn't fixed with a stent and is moderately severe.You cannot have an MRI scan if you have certain metal implants, devices, or conditions that make it unsafe.I have had treatment for a blockage in my heart's main or side arteries.I am scheduled for a heart vessel procedure within a week after my initial treatment.My heart attack was caused by a clot in or near a stent.I am in the hospital due to COVID-19.I have had coronary artery bypass surgery.I tested positive for COVID-19 recently but have not felt sick.I need a stent for my heart's main artery blockage.I do not have severe heart valve problems or heart muscle disease.I have had a procedure to open a blocked artery in my heart.I experienced severe heart issues during a heart procedure.
Research Study Groups:
This trial has the following groups:- Group 1: PCI with SSO2 therapy
- Group 2: anterior AMI patients treated with PCI and stenting within 6 hours
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining open slots in this experiment?
"According to clinicaltrials.gov, this medical trial is not actively enrolling patients at the moment. The study was first posted on August 2nd 2022 and last updated February 2nd 2023. However, there are 360 other studies currently recruiting volunteers for participation."
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