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Cardiogenic ShockISO-SHOCKNCT04876040

Incorporating Supersaturated Oxygen in Shock

A study testing SSO2 Downstream System and PCI + Impella in people with Cardiogenic Shock and STEMI, run by TherOx at 7 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock (STEMI-CS)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock, STEMI
What is being tested?
SSO2 Downstream System and PCI + Impella
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
7 sitesUnited States
Study dates
17 Dec 2021to Jun 2025
Phase
Interventional
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

Who may be able to join

  • 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:
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  • 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).

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Baptist Health South Florida

    Miami, Florida, 33176

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • WakeMed

    Raleigh, North Carolina, 27610

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

Other trials in United States

About this study

Official title: A Multi-Center Randomized-Controlled Trial To Evaluate The Safety And Feasibility of The Delivery Of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy For 60 Minutes In Patients With St Elevation Myocardial Infarction (STEMI) And Cardiogenic Shock After Successful Reperfusion (Via PCI) ≤ Six Hours After Symptom Onset Compared To Standard Therapy

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.

Being tested
SSO2 Downstream System, PCI + Impella
Keywords
Supersaturated Oxygen, SSO2
Medical subject headings
Shock, Cardiogenic, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSO2 Downstream SystemDevice

    60-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting.

  • PCI + ImpellaProcedure or surgery

    Standard of Care Intervention

Study groups in NCT04876040
Study groupRoleWhat they receive
PCI+Impella plus SSO2ExperimentalPatients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated post-procedure with an infusion of SSO2 Therapy for a duration of 60 minutes.
Receives: Device: SSO2 Downstream System; Procedure: PCI + Impella
PCI+ImpellaActive comparatorPatients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated with Standard of Care.
Receives: Procedure: PCI + Impella

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality at 30-days in the SSO2 group rate compared with the control group rate

    Primary Safety Endpoint

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start17 Dec 2021
  3. Primary completion17 Jan 2024
  4. Study completionJun 2025 (estimated)

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04876040
Sponsor's protocol ID
ISO-SHOCK
Acronym
ISO-SHOCK
Status last verified
Jan 2024
First submitted
3 May 2021
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SSO2 Downstream System and PCI + Impella in people with Cardiogenic Shock and STEMI, run by TherOx at 7 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 19 inclusion and 46 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: withdrawn, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 withdrawn before enrolling participants, so there are no results.

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?

All cause mortality at 30-days in the SSO2 group rate compared with the control group rate (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04876040.

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 24 Jan 2024.

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