434 Participants Needed

SSO2 Therapy for Heart Attack

SL
JC
Overseen ByJeffrey Creech, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: TherOx
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy

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.

What data supports the effectiveness of the SSO2 Therapy for Heart Attack treatment?

The research suggests that oxygen therapy can improve tissue oxygenation after cardiac surgery, which may support the idea that increasing oxygen levels in the blood could help heart attack patients recover better.12345

Is SSO2 Therapy for Heart Attack safe for humans?

The safety of procedures like Percutaneous Transluminal Coronary Angioplasty (PTCA) and the use of stents, which are related to SSO2 Therapy, has been studied. These procedures generally have a low risk, with complications like abrupt vessel closure occurring in a small percentage of cases. Mortality rates are less than 1%, indicating that these treatments are generally safe for humans.678910

How does SSO2 Therapy for heart attack differ from other treatments?

SSO2 Therapy is unique because it involves delivering supersaturated oxygen directly to the heart muscle after a heart attack, aiming to reduce damage by enhancing oxygen delivery, unlike traditional treatments like thrombolysis or angioplasty that focus on reopening blocked arteries.89111213

Research Team

JB

James Blankenship, MD

Principal Investigator

University of New Mexico

AS

Amir S Lotfi, MD

Principal Investigator

Baystate Health

GS

Gregg Stone, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

I am 18 years old or older.
My heart condition allows for a specific catheter placement for treatment.
You had a specific type of heart attack called an anterior myocardial infarction.
See 6 more

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.
See 27 more

Timeline

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)

Treatment Details

Interventions

  • PCI
  • TherOx DownStream System
Trial OverviewThe 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.
Participant Groups
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

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

πŸ‡ͺπŸ‡Ί
Approved in European Union as PCI for:
  • Acute Coronary Syndrome (ACS)
  • Stable Ischemic Heart Disease (SIHD)
  • Heart Attack
  • Coronary Artery Disease
πŸ‡ΊπŸ‡Έ
Approved in United States as PCI for:
  • Acute Myocardial Infarction (AMI)
  • Unstable Angina
  • Stable Angina
  • Coronary Artery Disease
πŸ‡¨πŸ‡¦
Approved in Canada as PCI for:
  • Acute Coronary Syndrome (ACS)
  • Stable Ischemic Heart Disease (SIHD)
  • Heart Attack
  • Coronary Artery Disease
πŸ‡―πŸ‡΅
Approved in Japan as PCI for:
  • Acute Myocardial Infarction (AMI)
  • Unstable Angina
  • Stable Angina
  • Coronary Artery Disease
πŸ‡¨πŸ‡³
Approved in China as PCI for:
  • Acute Coronary Syndrome (ACS)
  • Stable Ischemic Heart Disease (SIHD)
  • Heart Attack
  • Coronary Artery Disease
πŸ‡¨πŸ‡­
Approved in Switzerland as PCI for:
  • Acute Myocardial Infarction (AMI)
  • Unstable Angina
  • Stable Angina
  • Coronary Artery Disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

TherOx

Lead Sponsor

Trials
6
Recruited
1,900+

Findings from Research

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.
Continuous SvO2 measurement in infants undergoing congenital heart surgery--first clinical experiences with a new fiberoptic probe.MΓΌller, M., LΓΆhr, T., Scholz, S., et al.[2019]
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.
Response of tissue oxygenation to systemic hyperoxia after cardiac surgery.Kuttila, K.[2019]
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.
[Value of continuous measurement of mixed venous oxygen saturation (SVO2) during coronary angioplasty].CarriΓ©, D., Boudjemaa, B., Derbel, F., et al.[2013]

References

Continuous SvO2 measurement in infants undergoing congenital heart surgery--first clinical experiences with a new fiberoptic probe. [2019]
Response of tissue oxygenation to systemic hyperoxia after cardiac surgery. [2019]
[Value of continuous measurement of mixed venous oxygen saturation (SVO2) during coronary angioplasty]. [2013]
Mixed venous versus central venous oxygen saturation in patients undergoing on pump beating coronary artery bypass grafting. [2021]
Inferior and Superior Vena Cava Saturation Monitoring After Neonatal Cardiac Surgery. [2022]
Four-year experience with Palmaz-Schatz stenting in coronary angioplasty complicated by dissection with threatened or present vessel closure. [2022]
[Interventional therapy of bypass stenoses]. [2016]
[Percutaneous transluminal coronary angioplasty in ischemic heart disease]. [2010]
[Therapy of acute myocardial infarct--primary PTCA or thrombolysis?]. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Intracoronary stents: a new approach to coronary artery dilatation. [2019]
11.United Statespubmed.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. [2019]
Coronary thrombolysis for evolving myocardial infarction. [2018]
13.United Statespubmed.ncbi.nlm.nih.gov
Thrombolytic therapy in acute myocardial infarction. [2005]