Incorporating Supersaturated Oxygen in Shock

NCT04876040 | Withdrawn DMC FDA Device

• 1 other identifier: ISO-SHOCK
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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 culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock (STEMI-CS) treated using a shock protocol.

Conditions

Cardiogenic Shock; STEMI

Keywords

Supersaturated Oxygen; SSO2

Outcome Measures

Primary Outcomes (1)

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

  Primary Safety Endpoint

  30 days

Study Arms (2)

PCI+Impella plus SSO2

EXPERIMENTAL

Patients 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.

Device: SSO2 Downstream System; Procedure: PCI + Impella

PCI+Impella

ACTIVE COMPARATOR

Patients who present with STEMI-CS will undergo treatment with Impella, followed by PCI. Subjects are then immediately treated with Standard of Care.

Procedure: PCI + Impella

Interventions

SSO2 Downstream System DEVICE

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

PCI+Impella plus SSO2

PCI + Impella PROCEDURE

Standard of Care Intervention

PCI+Impella; PCI+Impella plus SSO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet ALL of the following criteria:
• 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.
• 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

You may not qualify if:

• Patients will be excluded if ANY of the following conditions apply:
• 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

Sponsors & Collaborators

• TherOx: lead

Study Sites (7)

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: December 17, 2021
• Primary Completion: January 17, 2024
• Study Completion: June 1, 2025
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)