SSO2 Therapy for Heart Attack

Overseen By Jeffrey Creech, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TherOx

Disqualifiers: Prior CABG, Prior MI, Renal impairment, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-procedure

434 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for heart attack patients to determine if adding supersaturated oxygen therapy (SSO2 Therapy) improves recovery compared to standard care. The focus is on patients who have experienced an anterior AMI and received a procedure to clear blocked arteries within six hours of symptom onset. The trial involves two groups: one receiving the new oxygen therapy alongside usual treatment and the other receiving only the usual treatment. Suitable candidates are those who have had a blockage in the heart’s main front artery treated within six hours of a heart attack, without any previous major heart surgeries or complications. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance heart attack recovery treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that supersaturated oxygen (SSO2) therapy, delivered through the TherOx DownStream System, has been tested in nearly 800 patients. Initial findings suggest it is generally well-tolerated. In one study, only 7.1% of patients experienced side effects within 30 days, including minor issues like one blocked stent and one case of bleeding. Importantly, no deaths occurred during that time.

Animal studies conducted before human testing also showed positive results, with improvements in heart function and metabolism. This suggests that the therapy is safe for humans, at least in the short term. While more data is always helpful, current evidence supports the safety of this treatment for heart attack patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard care for heart attacks, which usually involves procedures like PCI with stenting, the SSO2 Therapy introduces a novel approach by infusing super-saturated oxygen directly to the heart tissue after PCI. Researchers are excited about this treatment because it aims to minimize heart tissue damage by delivering highly concentrated oxygen, potentially enhancing recovery and improving heart function. This method offers a new way to support heart healing that standard treatments don't provide, possibly leading to better outcomes for patients who have experienced a heart attack.

What evidence suggests that this trial's treatments could be effective for heart attack?

This trial will compare two treatment approaches for heart attack patients. One group will receive PCI with SSO2 therapy, while the other group will receive PCI with stenting alone. Studies have shown that SSO2 therapy, when used after a procedure to open blocked arteries in patients with a specific type of heart attack, can lead to better outcomes. Specifically, research indicates that patients who received this therapy had fewer deaths and heart problems after one year compared to those who did not. In another study, the rate of negative events was low, with no deaths at 30 days. Animal studies also demonstrated that SSO2 therapy improved heart function immediately after treatment. Overall, these findings suggest that SSO2 therapy can effectively improve heart health after a heart attack. ^{1 2 3 4 5}

Who Is on the Research Team?

James Blankenship, MD

Principal Investigator

University of New Mexico

Gregg Stone, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Amir S Lotfi, MD

Principal Investigator

Baystate Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart condition allows for a specific catheter placement for treatment.

You had a specific type of heart attack called an anterior myocardial infarction.

My heart's main artery has been stented.

Exclusion Criteria

I had a stent placed in my heart and it caused a heart attack.

Subject has a known hypersensitivity or contraindication to any of the required study medications or contrast that cannot be adequately premedicated

You have a blockage of more than 20% in the main artery of your heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive PCI with stenting, followed by randomization to either SSO2 Therapy for 60 minutes or standard care

Immediate post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measured at 12 months

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PCI
• TherOx DownStream System

Trial Overview 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.

How Is the Trial Designed?

Group I: PCI with SSO2 therapy Experimental Treatment 2 Interventions

AMI subjects treated with SSO2 Therapy following PCI with stenting

Group II: anterior AMI patients treated with PCI and stenting within 6 hours Active Control 1 Intervention

Control group receiving PCI with stenting alone

PCI is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as PCI for:

• Acute Coronary Syndrome (ACS)
• Stable Ischemic Heart Disease (SIHD)
• Heart Attack
• Coronary Artery Disease

Approved in United States as PCI for:

• Acute Myocardial Infarction (AMI)
• Unstable Angina
• Stable Angina
• Coronary Artery Disease

Approved in Canada as PCI for:

• Acute Coronary Syndrome (ACS)
• Stable Ischemic Heart Disease (SIHD)
• Heart Attack
• Coronary Artery Disease

Approved in Japan as PCI for:

• Acute Myocardial Infarction (AMI)
• Unstable Angina
• Stable Angina
• Coronary Artery Disease

Approved in China as PCI for:

• Acute Coronary Syndrome (ACS)
• Stable Ischemic Heart Disease (SIHD)
• Heart Attack
• Coronary Artery Disease

Approved in Switzerland as PCI for:

• Acute Myocardial Infarction (AMI)
• Unstable Angina
• Stable Angina
• Coronary Artery Disease

Who Is Running the Clinical Trial?

TherOx

Lead Sponsor

Trials

6

Recruited

1,900+

Published Research Related to This Trial

Direct percutaneous transluminal coronary angioplasty (PTCA) shows a high success rate of 87% in real-world settings for treating acute myocardial infarction (AMI), but its clinical advantage over thrombolysis is minimal, with no significant differences in survival or reinfarction rates after 6 months.

Failed PTCA procedures are associated with a very high mortality rate of 36%, highlighting the risks involved and suggesting that improvements in PTCA techniques, such as coronary stenting and the use of GP IIb/IIIa platelet antagonists, may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapy of acute myocardial infarct--primary PTCA or thrombolysis?]. Vogt, A., Neuhaus, KL.[2019]

The new percutaneous fiberoptic probe for continuous monitoring of central venous saturation (SvO2) is feasible and safe for use in infants undergoing complex congenital heart surgery, as demonstrated in three cases during modifications of the Stage 1-Norwood-Procedure.

This technique reduces the risk of complications, such as bleeding during catheter removal, compared to traditional transthoracic catheter placement, making it a preferred method in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous SvO2 measurement in infants undergoing congenital heart surgery--first clinical experiences with a new fiberoptic probe. Müller, M., Löhr, T., Scholz, S., et al.[2019]

In a study comparing direct angioplasty (PTCA) and thrombolytic therapy (t-PA) for treating ST-segment elevation myocardial infarction, women showed a higher absolute benefit from PTCA, preventing more major events compared to men (56 events per 1000 women vs 42 events per 1000 men).

Despite women having a higher event rate and being older with more comorbidities like diabetes and hypertension, the relative effectiveness of PTCA compared to t-PA was similar for both sexes, indicating that while both treatments are effective, women may experience greater overall benefits from PTCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of direct angioplasty for women and men with acute myocardial infarction: results of the Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes Angioplasty (GUSTO II-B) Angioplasty Substudy. Tamis-Holland, JE., Palazzo, A., Stebbins, AL., et al.[2019]

Percutaneous balloon angioplasty (PTCA) in aorto-coronary saphenous vein grafts is highly risky, with significant rates of complications such as distal embolizations and myocardial infarctions, leading to increased mortality.

Recent advancements in stent designs, antiaggregatory treatments, and embolus protection devices show promise in improving the safety and effectiveness of PTCA procedures for these complex lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interventional therapy of bypass stenoses]. Baldus, S., Hamm, CW.[2016]

In a study of 26 patients undergoing percutaneous transluminal coronary angioplasty (PTCA), mixed venous oxygen saturation (SVO2) was found to be a reliable indicator of cardiac output during prolonged balloon inflation, regardless of the duration of inflation.

Patients with single vessel disease and good left ventricular function showed different SVO2 responses compared to those with triple vessel disease and poor left ventricular function, highlighting the importance of monitoring SVO2 to evaluate hemodynamic tolerance in different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value of continuous measurement of mixed venous oxygen saturation (SVO2) during coronary angioplasty]. Carrié, D., Boudjemaa, B., Derbel, F., et al.[2013]

Early thrombolytic therapy can significantly reduce hospital mortality after a heart attack by 20-50% and limit the size of the heart damage, preserving heart function.

While thrombolytic therapy is generally safe, with a low risk of serious bleeding complications (about 0.5% for intracranial bleeding), it is most effective when administered shortly after symptoms begin, ideally within six hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thrombolytic therapy in acute myocardial infarction. Simoons, ML.[2005]

In a study of 118 neonates with congenital heart disease, admission inferior vena cava oxygen saturation (IVC O2) was found to correlate with superior vena cava oxygen saturation (SVC O2), but IVC O2 levels were significantly lower, indicating potential differences in hemodynamic status post-surgery.

A decrease in IVC O2 was strongly associated with a higher risk of adverse outcomes, such as increased serum lactate or the need for vasoactive support, suggesting that monitoring IVC O2 could be crucial for identifying neonates at risk for low cardiac output and related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inferior and Superior Vena Cava Saturation Monitoring After Neonatal Cardiac Surgery. Law, MA., Benscoter, AL., Borasino, S., et al.[2022]

Percutaneous transluminal coronary angioplasty (PTCA) has a high primary success rate of 85-95% for treating coronary artery stenoses, making it an effective option for patients with few or short blockages.

While PTCA has low complication rates, with mortality less than 1%, it does have a risk of recurrence of cardiac events, particularly due to restenosis, affecting 15-30% of patients with one-vessel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous transluminal coronary angioplasty in ischemic heart disease]. Thayssen, P.[2010]

Percutaneous transluminal coronary angioplasty (PTCA) is generally a low-risk procedure for treating coronary artery disease, but it carries risks of abrupt closure (3.6% of patients) and restenosis (30% average rate).

The use of intracoronary stents after balloon angioplasty is being studied as a method to prevent these complications by maintaining the artery's diameter, which could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracoronary stents: a new approach to coronary artery dilatation. Bevans, M., McLimore, E.[2019]

In a study of 339 patients, Palmaz-Schatz stenting after percutaneous transluminal coronary angioplasty (PTCA) showed a high success rate of 96.5% and resulted in low early mortality (1.3%) and myocardial infarction (4.0%) rates, indicating its safety and efficacy in managing occlusions.

The long-term outcomes were promising, with a 2-year survival rate of 95.4% and an event-free survival rate of 70.7%, suggesting that stenting can effectively prevent major adverse events in patients at risk after PTCA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-year experience with Palmaz-Schatz stenting in coronary angioplasty complicated by dissection with threatened or present vessel closure. Schömig, A., Kastrati, A., Mudra, H., et al.[2022]

In a study of eight patients after coronary artery bypass grafting, the opening of peripheral circulation was indicated by increased cardiac index and decreased mean arterial pressure, alongside rises in skin temperature and subcutaneous oxygen levels during oxygen ventilation.

The findings suggest that simply increasing systemic oxygen levels (hyperoxia) does not effectively improve peripheral tissue oxygenation until the peripheral blood vessels are opened, highlighting the importance of vascular function in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response of tissue oxygenation to systemic hyperoxia after cardiac surgery. Kuttila, K.[2019]

In a study of 34 adult patients undergoing coronary artery bypass grafting, central venous oxygen saturation (ScvO(2)) consistently showed higher readings than mixed venous oxygen saturation (SvO(2)), indicating they are not numerically interchangeable.

While ScvO(2) can be used to track trends in oxygen saturation, the significant differences in absolute values, especially after cardiopulmonary bypass, suggest that it should not replace SvO(2) when precise measurements are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mixed venous versus central venous oxygen saturation in patients undergoing on pump beating coronary artery bypass grafting. Alshaer, A., Abdel-Meguid, ME., Ibraheim, O., et al.[2021]

Thrombolytic therapy, particularly using streptokinase, can effectively restore blood flow in coronary arteries, achieving reperfusion in 75% of patients with intracoronary administration and 50-80% with intravenous administration, which is crucial for reducing heart damage during a myocardial infarction.

While thrombolytic therapy significantly reduces mortality rates at 30 days and 6 months post-infarction, it carries a risk of serious bleeding, particularly with intracoronary use (4.8%) compared to intravenous use (0.8% to 12.8%), highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary thrombolysis for evolving myocardial infarction. Spann, JF., Sherry, S.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8246818/

One‐year outcomes of supersaturated oxygen therapy in ... Infusion of SSO2 following pPCI in patients with anterior STEMI was associated with improved 1‐year clinical outcomes including lower rates of death and new‐ ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170027B.pdf

TherOx DownStream System - accessdata.fda.gov The pre-clinical animal studies conducted with the TherOx DownStream System in AMI models have demonstrated acute improvements in cardiac function and metabolic.

3. citoday.com citoday.com/articles/2019-july-aug/supersaturated-oxygen-therapy-for-stemi

SuperSaturated Oxygen Therapy for STEMI This primary endpoint was met with a net adverse clinical events rate of 7.1% at 30 days; there were no deaths, one instance of stent thrombosis, and one case ...

4. zoll.com zoll.com/en-us/products/therapies-and-treatments/cardiovascular/clinical

SuperSaturated Oxygen Therapy: Clinical Overview TherOx has conducted several clinical studies to establish the safety and effectiveness of SSO2 Therapy. In total, nearly 800 patients have been clinically ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02603835

Evaluation of Intracoronary Hyperoxemic Oxygen Therapy ... The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute ...