Incorporating Supersaturated Oxygen in Shock

Withdrawn before enrolling · Not applicable

Conditions studied: Cardiogenic Shock, STEMI

In brief

A multi-center, prospective randomized (1:1) pilot and feasibility study to evaluate the safety and feasibility of supersaturated oxygen (SSO2) therapy delivered for 60 minutes selectively into the culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock (STEMI-CS) treated using a shock protocol.

Key facts

Study ID

NCT04876040

Run by

TherOx

People needed

0

Starts

2021-12-17

Expected to finish

2025-06-01

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet ALL of the following criteria:
• GENERAL INCLUSION CRITERIA: Candidates for this study must meet ALL of the following criteria prior to randomization:
• Pre-PCI:
• The patient must be ≥18 years of age.
• Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI).
• Cardiogenic shock is defined by the presence of at least 2 of the below criteria:
• Hypotension due to a primary cardiac cause (systolic blood pressure [SBP] <90 mmHg refractory to urgent medical care and/or not responsive to initial medical care or requiring inotropes or vasopressors or mechanical circulatory support to maintain SBP >90 mmHg)
• Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels)
• Hemodynamic criteria represented by cardiac index <2.2 L/min/m2 or cardiac power output (CPO) <0.6 W.
• Patient had pulmonary artery catheters placed for hemodynamic monitoring for clinical reasons
• Patient is treated with mechanical circulatory support with an Impella CP.
• Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written or remote/electronic informed consent, approved by the appropriate Institutional Review Board (IRB).
• Patient or legally authorized representative and his/her physician agree to all required follow-up procedures and visits.
• ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the patient has undergone cardiac catheterization and PCI and has provided signed Informed Consent:
• Based on coronary anatomy, PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent (bare metal or drug-eluting, at operator discretion).
• Successful angioplasty with stenting is completed <6 hrs from AMI symptom onset, as documented by less than 30% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation.
• For coronary intervention, intravenous antiplatelet agents were used
• Expected ability to place the SSO2 delivery catheter in the coronary ostium to deliver SSO2 Therapy with stable, coaxial alignment.
• Systemic arterial pO2 greater than or equal to 80 mmHg as measured by arterial blood gas (may be repeated if low after supplemental O2 administration).

You may not qualify if…

• Patients will be excluded if ANY of the following conditions apply:
• GENERAL EXCLUSION CRITERIA
• Pre-PCI:
• A surgical procedure is planned during the first 30 days post-enrollment.
• Contraindication to MRI imaging, including any of the following:
• Non-MRI compatible cardiac pacemaker or implantable defibrillator;
• Non-MRI compatible aneurysm clip or other metallic implants;
• Neural Stimulator (i.e., TENS unit);
• Any implanted or magnetically activated device (insulin pump);
• Any type of non-MRI compatible ear implant;
• Metal shavings in the orbits;
• Any indwelling metallic foreign body, shrapnel, or bullet;
• Any condition contraindicating MRI, including claustrophobia;
• Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and
• Known hypersensitivity or contraindication to gadolinium contrast.
• All unwitnessed out of hospital cardiac arrest or any witnessed cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes or any neurological injury
• Evidence of anoxic brain injury on admission (including posturing, seizures, loss of brain stem reflexes)
• Use of IABP
• Septic, anaphylactic, hemorrhagic, or neurologic causes of shock
• Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
• Known previous myocardial infarction, in the same territory as present AMI
• Active bleeding for which mechanical circulatory support is contraindicated.
• Patient has history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary.
• Contraindication to intravenous systemic anticoagulation
• Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)

Where it is running

• Baptist Health South Florida — Miami, Florida, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• WakeMed — Raleigh, North Carolina, United States
• Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Prisma Health Greenville Memorial Hospital — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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