RECRUITING

Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A multi-center randomized post-approval evaluation of delivery of intracoronary hyperoxemic supersaturated Oxygen therapy for 60 minutes in anterior AMI patients with successful reperfusion (via PCI) within 6 hours after onset of symptoms compared to standard therapy

Official Title

A Post Approval Study to Evaluate the Delivery of Hyperoxemic Super Saturated Oxygen Therapy for 60 Minutes in Anterior AMI Patients Compared to PCI

Quick Facts

Study Start:2022-08-02

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04743245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. The subject must be ≥18 years of age. 2. AMI must be anterior (ST-segment elevation \>1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block). 3. The subject or 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) or Ethics Committee (EC). 4. Subject and his/her physician agree to all required follow-up procedures and visits.	1. Prior CABG surgery. 2. Prior myocardial infarction or known prior systolic dysfunction (e.g. due to cardiomyopathy); this criterion does not include left ventricular dysfunction induced by the acute MI. 3. An elective surgical procedure is planned during the first 30 days post-enrollment. 4. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI. 5. Subjects who have previously undergone an angioplasty or stenting procedure in the left anterior descending coronary artery. 6. Contraindication to MRI imaging, including any of the following: 1. Non-MRI compatible cardiac pacemaker or implantable defibrillator; 2. Non-MRI compatible aneurysm clip or other metallic implants; 3. Neural Stimulator (i.e., TENS unit); 4. Any implanted or magnetically activated device (insulin pump); 5. Any type of non-MRI compatible ear implant; 6. Metal shavings in the orbits; 7. Any indwelling metallic foreign body, shrapnel, or bullet; 8. Any condition contraindicating MRI, including claustrophobia; 9. Inability to follow breath hold instructions or to maintain a breath hold for \>15 seconds; and 10. Known hypersensitivity or contraindication to gadolinium contrast. 7. Known impaired renal function (creatinine clearance \<30 ml/min/1.73 m2 by the MDRD formula) or on dialysis. 8. Known platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a known Hgb \<10 g/dL. 9. Subject has active bleeding or a history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary. 10. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke. 11. Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect. 12. Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment. 13. Subject has received any organ transplant or is on a waiting list for any organ transplant. 14. Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the protocol, confound the data interpretation, or is associated with life expectancy of less than one year. 15. Subject has a known hypersensitivity or contraindication to any of the required study medications or contrast that cannot be adequately premedicated. 16. Subjects presenting with or developing in the cath lab prior to completion of the PCI procedure any of the following conditions: cardiogenic shock (SBP \<80 mmHg for \>30 minutes), or requiring IV pressors or emergent placement of an intra-aortic balloon pump (IABP), Impella, or other hemodynamic support for hypotension treatment, or cardiopulmonary resuscitation for \>10 minutes, or ventricular fibrillation or tachycardia requiring cardioversion or defibrillation. 17. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or cardiomyopathy. 18. Subject 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 subject'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.). 19. Current participation in other investigational device or drug study that has not reached its primary endpoint. 20. Previous enrollment in this study. 21. Subject is currently hospitalized for definite or suspected COVID-19. 22. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and had returned to his/her prior baseline (pre-COVID) clinical condition. 23. Subject is asymptomatic (never ill) and COVID-19 PCR/antigen or antibody test is positive within the prior 4 weeks unless subject remained asymptomatic for≥4 weeks after the last positive test.

Inclusion Criteria

Exclusion Criteria

1. The subject must be ≥18 years of age.
2. AMI must be anterior (ST-segment elevation \>1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block).
3. The subject or 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) or Ethics Committee (EC).
4. Subject and his/her physician agree to all required follow-up procedures and visits.

1. Prior CABG surgery.
2. Prior myocardial infarction or known prior systolic dysfunction (e.g. due to cardiomyopathy); this criterion does not include left ventricular dysfunction induced by the acute MI.
3. An elective surgical procedure is planned during the first 30 days post-enrollment.
4. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
5. Subjects who have previously undergone an angioplasty or stenting procedure in the left anterior descending coronary artery.
6. Contraindication to MRI imaging, including any of the following:
1. Non-MRI compatible cardiac pacemaker or implantable defibrillator;
2. Non-MRI compatible aneurysm clip or other metallic implants;
3. Neural Stimulator (i.e., TENS unit);
4. Any implanted or magnetically activated device (insulin pump);
5. Any type of non-MRI compatible ear implant;
6. Metal shavings in the orbits;
7. Any indwelling metallic foreign body, shrapnel, or bullet;
8. Any condition contraindicating MRI, including claustrophobia;
9. Inability to follow breath hold instructions or to maintain a breath hold for \>15 seconds; and
10. Known hypersensitivity or contraindication to gadolinium contrast.
7. Known impaired renal function (creatinine clearance \<30 ml/min/1.73 m2 by the MDRD formula) or on dialysis.
8. Known platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a known Hgb \<10 g/dL.
9. Subject has active bleeding or a history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary.
10. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
11. Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
12. Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment.
13. Subject has received any organ transplant or is on a waiting list for any organ transplant.
14. Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the protocol, confound the data interpretation, or is associated with life expectancy of less than one year.
15. Subject has a known hypersensitivity or contraindication to any of the required study medications or contrast that cannot be adequately premedicated.
16. Subjects presenting with or developing in the cath lab prior to completion of the PCI procedure any of the following conditions: cardiogenic shock (SBP \<80 mmHg for \>30 minutes), or requiring IV pressors or emergent placement of an intra-aortic balloon pump (IABP), Impella, or other hemodynamic support for hypotension treatment, or cardiopulmonary resuscitation for \>10 minutes, or ventricular fibrillation or tachycardia requiring cardioversion or defibrillation.
17. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or cardiomyopathy.
18. Subject 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 subject'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.).
19. Current participation in other investigational device or drug study that has not reached its primary endpoint.
20. Previous enrollment in this study.
21. Subject is currently hospitalized for definite or suspected COVID-19.
22. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and had returned to his/her prior baseline (pre-COVID) clinical condition.
23. Subject is asymptomatic (never ill) and COVID-19 PCR/antigen or antibody test is positive within the prior 4 weeks unless subject remained asymptomatic for≥4 weeks after the last positive test.

Contacts and Locations

Study Contact

Jeffrey Creech, PhD

CONTACT

3233096949

jcreech@zoll.com

Shailaja Lakma

CONTACT

9253367743

slakma@zoll.com

Principal Investigator

James Blankenship, MD

PRINCIPAL_INVESTIGATOR

University of New Mexico

Gregg Stone, MD

STUDY_CHAIR

MOUNT SINAI HOSPITAL

Amir S Lotfi, MD

STUDY_DIRECTOR

Baystate Health

Study Locations (Sites)

Baystate Medical Center

Springfield, Massachusetts, 01199

United States

Collaborators and Investigators

Sponsor: TherOx

James Blankenship, MD, PRINCIPAL_INVESTIGATOR, University of New Mexico
Gregg Stone, MD, STUDY_CHAIR, MOUNT SINAI HOSPITAL
Amir S Lotfi, MD, STUDY_DIRECTOR, Baystate Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-02

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2022-08-02

Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

Acute Myocardial Infarction
STEMI