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Status:

WITHDRAWN

Incorporating Supersaturated Oxygen in Shock

Lead Sponsor:

TherOx

Conditions:

Cardiogenic Shock

STEMI

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 cu...

Eligibility Criteria

Inclusion

  • 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).

Exclusion

  • 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)
  • Known left ventricular thrombus for which mechanical circulatory support with Impella is contraindicated
  • Mechanical aortic prosthetic valve or self-expanding TAVR (note: prior bioprosthetic surgical valve or balloon-expandable TAVR implanted \>24 hours pre-procedure is acceptable)
  • Known impaired renal function (creatinine clearance \<30 ml/min/1.73 m2 by the MDRD formula) or on dialysis.
  • History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
  • Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
  • Gastrointestinal or genitourinary bleeding within the last two (2) months.
  • Any major surgery (including CABG) within six weeks of enrollment.
  • Patient has received any organ transplant or is on a waiting list for any organ transplant.
  • Patient has other medical illness (e.g., cancer, dementia) with life expectancy of less than one year.
  • Patient has a known hypersensitivity or contraindication to any of the required study medications or contrast that cannot be adequately premedicated.
  • Patient with severe peripheral arterial disease in whom mechanical circulatory support cannot be safely established (or who require a smaller device such as an IABP).
  • Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or cardiomyopathy.
  • Patient is a member of a vulnerable population or has any significant medical or social condition which in the investigator's opinion may interfere with the patient's participation in the study or ability to comply with follow-up procedures, including MRI (e.g. alcoholism, dementia, lives far from the research center, etc.).
  • Current participation in other investigational device or drug study that has not reached its primary endpoint.
  • Symptoms consistent with isolated right ventricular cardiogenic shock (this study is intended to enroll patients experiencing cardiogenic shock from predominant left ventricular dysfunction).
  • Previous enrollment in this study.
  • Subject is currently hospitalized for definite or suspected COVID-19.
  • ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the patient has provided signed Informed Consent and has undergone cardiac catheterization and PCI if indicated:
  • Left ventriculography or high-quality echocardiography (at least one of which is mandatory either before or after PCI, but in all cases before randomization) demonstrates severe mitral regurgitation with concerns of papillary muscle rupture, a ventricular septal defect, a pseudoaneurysm, aortic dissection or other mechanical complications of MI.
  • Any unrevascularized left main or ostial right coronary artery stenosis \>50%, which would preclude use of the delivery catheter.
  • Presence of a non-stented coronary dissection with NHLBI grade \>B upon completion of the PCI procedure.

Key Trial Info

Start Date :

December 17 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04876040

Start Date

December 17 2021

End Date

June 1 2025

Last Update

January 24 2024

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

Baptist Health South Florida

Miami, Florida, United States, 33176

2

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

3

Henry Ford Health System

Detroit, Michigan, United States, 48202

4

WakeMed

Raleigh, North Carolina, United States, 27610