SSO2 Therapy for Heart Attack
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?
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?
Research Team
James Blankenship, MD
Principal Investigator
University of New Mexico
Amir S Lotfi, MD
Principal Investigator
Baystate Health
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PCI with stenting, followed by randomization to either SSO2 Therapy for 60 minutes or standard care
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary outcome measured at 12 months
Treatment Details
Interventions
- PCI
- TherOx DownStream System
PCI is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Acute Coronary Syndrome (ACS)
- Stable Ischemic Heart Disease (SIHD)
- Heart Attack
- Coronary Artery Disease
- Acute Myocardial Infarction (AMI)
- Unstable Angina
- Stable Angina
- Coronary Artery Disease
- Acute Coronary Syndrome (ACS)
- Stable Ischemic Heart Disease (SIHD)
- Heart Attack
- Coronary Artery Disease
- Acute Myocardial Infarction (AMI)
- Unstable Angina
- Stable Angina
- Coronary Artery Disease
- Acute Coronary Syndrome (ACS)
- Stable Ischemic Heart Disease (SIHD)
- Heart Attack
- Coronary Artery Disease
- 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