Anterior Acute Myocardial Infarction (AMI)REALNCT05156996
A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System
An observational study of Anterior Acute Myocardial Infarction (AMI), run by TherOx at 2 sites in United States.
Trial summary
The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Acute Myocardial Infarction (AMI)
- What is being tested?
- Supersaturated O2 Therapy of the Therox Downstream System® and PCI alone
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2022to 24 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient who meets the protocol defined eligibility criteria and none of the exclusion criteria at the time of completion of index procedure and who consents to participate.
Who may be able to join
- Men or women aged 18 years or older.
- Presentation with anterior acute ST-elevation myocardial infarction (> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4).
- The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions may be treated if clinically indicated).
- Successful angioplasty within 6 hours of symptom onset, as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.
- The patient or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB).
- Patient and his/her physician agree to all required follow-up procedures and visits.
Who cannot join
- Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated.
- Presence of an intra-aortic balloon pump.
- Proximal coronary stenosis that would restrict flow with the SSO2 Catheter in place
- Presence of a post-intervention non-stented coronary dissection or perforation.
- Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
- Pregnant or nursing women.
Show all 12Show fewer
- Cardiogenic shock.
- Patients contraindicated for anticoagulation therapy.
- Patients with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
- Hemoglobin < 10 g/dL.
- Gastrointestinal or genitourinary bleeding within the last two months, or any major surgery (including CABG) within six weeks of procedure.
- Patients with active COVID-19 infection.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Charleston Area Medical Center
Charleston, West Virginia, 25304
St. Mary's Medical Center
Huntington, West Virginia, 25702
About this study
Official title: A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System After PCI vs. PCI Alone Among Patients Undergoing PCI for Acute Anterior Myocardial Infarction
The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI.
- Being tested
- Supersaturated O2 Therapy of the Therox Downstream System®, PCI alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supersaturated O2 Therapy of the Therox Downstream System®Device
SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient's left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
PCI aloneProcedure or surgery
Percutaneous Coronary Intervention for treatment of acute MI
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Not described Receives: Device: Supersaturated O2 Therapy of the Therox Downstream System® | |
| Control Group | Not described Receives: Procedure: PCI alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of Cardiovascular Death
Measured: 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of Heart Transplant or LVAD
Measured: 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of ICD/CRT device implanted
Measured: 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of Rehospitalization for heart failure between discharge and 12 months post-procedure
Measured: 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Rate of KCCQ-OS score at 1 year
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start4 Dec 2022
- Primary completion4 Jan 2024
- Study completion24 Apr 2024
Why it stopped: Transitioning to a new Registry trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- TherOx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156996
- Sponsor's protocol ID
- REAL SSO2
- Acronym
- REAL
- Status last verified
- May 2024
- First submitted
- 2 Nov 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Real-World Multi-Center Post-Market Observational Evaluation of Supersaturated O2 Therapy Using the TherOx® Downstream® System After PCI vs. PCI Alone Among Patients Undergoing PCI for Acute Anterior Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05156996
- Acronym / sponsor ID
- REAL / REAL SSO2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Transitioning to a new Registry trial
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TherOxIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect real-world data on the TherOx DownStream System® to assess the effectiveness and cost- effectiveness of SSO2 Therapy, compared with PCI alone for treatment of patients with acute anterior MI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: Supersaturated O2 Therapy of the Therox Downstream System® |
| Control Group | – | Procedure: PCI alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient who meets the protocol defined eligibility criteria and none of the exclusion criteria at the time of completion of index procedure and who consents to participate.
Key inclusion criteria (6 listed)
- Men or women aged 18 years or older.
- Presentation with anterior acute ST-elevation myocardial infarction (> 1 mm ST-segment elevation in two or more contiguous leads between V1 and V4).
- The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions may be treated if clinically indicated).
- Successful angioplasty within 6 hours of symptom onset, as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.
- The patient or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB).
Key exclusion criteria (12 listed)
- Ipsilateral insertion of a second sheath in a single femoral artery for SuperSaturated Oxygen Therapy is strictly contraindicated.
- Presence of an intra-aortic balloon pump.
- Proximal coronary stenosis that would restrict flow with the SSO2 Catheter in place
- Presence of a post-intervention non-stented coronary dissection or perforation.
- Cardiac valvular stenosis or insufficiency, pericardial disease or non-ischemic cardiomyopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supersaturated O2 Therapy of the Therox Downstream System®SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient's left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion. | Device | Treatment Group |
| PCI alonePercutaneous Coronary Intervention for treatment of acute MI | Procedure or surgery | Control Group |
Primary outcome
Measures (hierarchical) at 12-months post-procedure include rates of:
Time frame: 12 months post-procedure
Rate of Cardiovascular Death
Measures (hierarchical) at 12-months post-procedure include rates of:
Time frame: 12 months post-procedure
Rate of Heart Transplant or LVAD
Measures (hierarchical) at 12-months post-procedure include rates of:
Time frame: 12 months post-procedure
Rate of ICD/CRT device implanted
Measures (hierarchical) at 12-months post-procedure include rates of:
Time frame: 12 months post-procedure
Rate of Rehospitalization for heart failure between discharge and 12 months post-procedure
Measures (hierarchical) at 12-months post-procedure include rates of:
Time frame: 12 months post-procedure
Rate of KCCQ-OS score at 1 year
Results and safety
The study was stopped early (reason given: Transitioning to a new Registry trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Acute Myocardial Infarction (AMI)
Recruiting
Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction
Intravascular Imaging and Microvascular Obstruction
RecruitingPhase 2
Rituximab in Patients With ST-elevation Myocardial Infarction
ST Elevated Myocardial Infarction
Not yet recruiting
Prophylactic IABP in Delayed-Presentation Anterior STEMI
Acute Anterior ST-Segment Elevation Myocardial Infarction
RecruitingPhase 2
A Research Study to Evaluate the Efficacy and Safety of SGC001 in Patients With Anterior Wall ST-Segment Elevation Myocardial Infarction
Acute Anterior ST-Segment Elevation Myocardial Infarction
Not yet recruitingPhase 2
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
Acute Myocardial Infarction (AMI), Acute Myocardial Infarction of Anterior Wall
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Acute Myocardial Infarction (AMI), run by TherOx at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Transitioning to a new Registry trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures (hierarchical) at 12-months post-procedure include rates of: (time frame: 12 months post-procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.