Your session is about to expire
← Back to Search
Other
Supersaturated Oxygen Therapy for Cardiogenic Shock (ISO-SHOCK Trial)
N/A
Waitlist Available
Research Sponsored by TherOx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Summary
This trial will study whether supersaturated oxygen therapy is safe and feasible for patients with ST elevation myocardial infarction and cardiogenic shock.
Who is the study for?
Adults with a heart attack and shock, who have low blood pressure despite treatment or need drugs to keep their blood pressure up. They must show signs of poor blood flow to organs, have specific heart function measurements, completed successful angioplasty for the heart attack within 6 hours of symptoms starting, and be able to receive SSO2 therapy. Exclusions include planned surgeries soon after enrollment, MRI contraindications like certain metal implants or claustrophobia, severe brain injury from lack of oxygen, recent stroke or major surgery history.Check my eligibility
What is being tested?
The trial is testing if delivering supersaturated oxygen (SSO2) into the artery affected by a heart attack can help patients in shock. It's done alongside standard treatments like angioplasty with stenting and mechanical support using Impella devices. Patients are randomly chosen to either get this additional SSO2 therapy or not as part of their care.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion such as inflammation at the site where it's delivered into the artery. There could also be risks associated with increased oxygen levels in that area which aren't fully known yet due to the investigational nature of this treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All cause mortality at 30-days in the SSO2 group rate compared with the control group rate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PCI+Impella plus SSO2Experimental Treatment2 Interventions
Patients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated post-procedure with an infusion of SSO2 Therapy for a duration of 60 minutes.
Group II: PCI+ImpellaActive Control1 Intervention
Patients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated with Standard of Care.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart attacks, such as Supersaturated Oxygen (SSO2) Therapy, aim to increase oxygen delivery to ischemic myocardial tissue, thereby reducing the extent of myocardial injury. SSO2 therapy involves delivering highly oxygenated blood directly to the affected coronary artery, which helps to minimize tissue damage and improve recovery.
This is crucial for heart attack patients as it can significantly reduce the size of the infarct, preserve heart function, and improve overall outcomes. Other treatments, like reperfusion therapy (e.g., angioplasty and thrombolytics), work by restoring blood flow to the blocked artery, further enhancing oxygen delivery and reducing ischemic damage.
Reduction of infarct size by oxygen inhalation following acute coronary occlusion.Therapeutic Hypothermia for Cardioprotection in Acute Myocardial Infarction.Effects of inotropic drugs on mechanical function and oxygen balance in postischemic canine myocardium: comparison of dobutamine, epinephrine, amrinone, and calcium chloride.
Reduction of infarct size by oxygen inhalation following acute coronary occlusion.Therapeutic Hypothermia for Cardioprotection in Acute Myocardial Infarction.Effects of inotropic drugs on mechanical function and oxygen balance in postischemic canine myocardium: comparison of dobutamine, epinephrine, amrinone, and calcium chloride.
Find a Location
Who is running the clinical trial?
TherOxLead Sponsor
5 Previous Clinical Trials
1,857 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI scan if you have a non-MRI compatible medical device, metal in your body, or any condition that prevents you from following instructions for the MRI.If you had a cardiac arrest and did not regain consciousness within 30 minutes, you won't be able to participate.You have signs of severe brain injury when you were admitted to the hospital, like unusual body movements, seizures, or loss of reflexes.You are using an intra-aortic balloon pump.You are currently in the hospital for confirmed or suspected COVID-19.You are experiencing heart failure mainly in the left side of your heart, not the right side.You have severe blockages in certain main heart arteries that would make it difficult to use the catheter during the study.You have a coronary dissection that is not treated with a stent and is graded higher than B by the NHLBI.You must be 18 years old or older.You have low blood pressure caused by a heart problem that doesn't improve with medical treatment or requires special medications or devices to maintain a safe blood pressure level.You show signs of poor blood flow to your organs, such as cool extremities, very little or no urine, or high lactate levels.Your heart is not pumping enough blood.Your kidneys do not work well, or you are on dialysis.You have certain heart complications after a heart attack, like a hole in the heart or damage to the heart valves.You have a blood clot in your heart that cannot be treated with a certain type of heart pump called Impella.You have a history of a specific type of brain mass, aneurysm, or bleeding stroke.You had a stroke or mini-stroke in the last six months, or have any lasting neurological problems.You have another serious illness, like cancer or dementia, and are not expected to live more than one year.You have severe peripheral arterial disease and cannot safely have mechanical circulatory support.Tests show that you have severe problems with the mitral valve or other mechanical issues after a heart attack.You have symptoms and test results that show you recently had a heart attack.If you recently had a procedure to open blocked blood vessels in your heart, it needs to have been done within 6 hours of having symptoms of a heart attack, and it must have been successful with no major problems.You have received intravenous medication to prevent blood clotting during a heart procedure.You are not experiencing low blood pressure due to specific non-heart related conditions like a blood clot in the lungs or a collapsed lung.You have a specific type of heart valve, or have had a certain type of heart valve replacement surgery within the past 24 hours.You have had bleeding in your stomach or intestines, or in your urinary system in the last two months.You have serious heart valve or muscle problems.You need to be able to place a catheter in a specific part of the heart to receive the treatment.Your blood oxygen level is higher than 80 mmHg when measured with a blood test.Your doctor has recommended using a coronary stent to fix a blocked artery.You had a catheter placed in your pulmonary artery for medical monitoring.You are using a device called Impella CP to help your heart pump blood.You have shock caused by severe infection, severe allergic reaction, severe bleeding, or severe neurologic issues.You have had a heart attack in the same area as the current one.You are currently bleeding and cannot use a device to help your heart pump blood.You have a history of bleeding disorders or clotting problems and are not willing to receive a blood transfusion if needed.You cannot receive anticoagulation medication through a vein.
Research Study Groups:
This trial has the following groups:- Group 1: PCI+Impella plus SSO2
- Group 2: PCI+Impella
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger