Anterior Wall Acute Myocardial Infarction
Conditions
Keywords
SSO2 Therapy, acute myocardial infarction, anterior myocardial infarction, SuperSaturated oxygen delivery, left main coronary artery, myocardial infarction, heart attack, percutaneous coronary intervention, cardiac catheterization laboratory, PCI, stent, stenting, stents, angioplasty, LMCA, Delivery of supersaturated oxygen (SSO2) therapy for the treatment of anterior acute myocardial infarction
Brief summary
The purpose of this study is to evaluate the feasibility of the delivery of SuperSaturated Oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA). The therapy will be delivered with a commercially available qualified SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the treatment of patients presenting with an anterior acute myocardial infarction (heart attack) ≤ six hours after symptom onset with successful reperfusion (via PCI).
Interventions
DEVICESuperSaturated Oxygen (SS02) Therapy
Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
Sponsors
TherOx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
GENERAL INCLUSION CRITERIA: Candidates for this study must meet ALL of the following criteria: Pre-PCI: 1. The subject must be ≥18 and ≤80 years of age. 2. AMI must be anterior. 3. Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration. 4. Signed Informed Consent. 5. Subject agrees to all required follow-up procedures and visits. 6. Negative pregnancy test for women of childbearing potential. ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment: 7. PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent in the LAD. 8. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery. 9. Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD. 10. Successful angioplasty and no major complications such as perforation or shock. 11. Expected ability to place the SSO2 delivery catheter in the coronary ostium of the left main coronary system to deliver SSO2 Therapy with stable, coaxial alignment. 12. Planned revascularization of a non-target lesion is allowed. Patients will be excluded if ANY of the following conditions apply: GENERAL
Exclusion criteria
Pre-PCI: 13. Prior CABG surgery. 14. Prior myocardial infarction, or known prior systolic dysfunction. 15. Thrombolytic therapy administered for this STEMI. 16. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment. 17. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI. 18. Subjects who have previously undergone angioplasty or stenting in the LAD. 19. Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation. 20. Any contraindication to undergo MRI imaging. 21. Impaired renal function or on dialysis. 22. Known platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a known Hgb \<10 g/dL. 23. Subject has active bleeding or a history of bleeding. 24. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke. 25. Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect. 26. Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment. 27. Subject has received any organ transplant or is on a waiting list for any organ transplant. 28. Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that a may cause non-compliance with the protocol. 29. Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated. 30. Current use of warfarin, dabigatran, or factor Xa inhibitors. 31. Subjects presenting with or developing in the cath lab: cardiogenic shock or ventricular fibrillation or tachycardia. 32. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy. 33. Any significant medical condition which in the investigator's opinion may interfere with the subject's optimal participation in the study. 34. Current participation in other investigational device or drug trials that have not finished the primary endpoint follow-up period. 35. Previous enrollment in this study. ANGIOGRAPHIC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Feasibility of Intracoronary Infusion of SSO2 Therapy | Procedure | Successful administration of SSO2 Therapy (60 minutes) without dislodgment of the SSO2 delivery catheter during the infusion and without untoward Serious Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Myocardial Salvage Index | 3 to 5 days post-procedure | Myocardial Salvage Index by cardiac MRI at 3-5 days post-procedure, read by an independent MRI core laboratory. Calculated as (1 - infarct mass / area at risk) × 100, with both quantified in grams of left ventricular myocardium. Range 0% (no salvage, entire area at risk infarcted) to 100% (no infarction within the area at risk). Higher values are better. |
| Median Infarct Size by Cardiac MRI | 3 to 5 days post-procedure | Infarct size by cardiac MRI with late gadolinium enhancement at 3-5 days post-procedure, read by an independent MRI core laboratory. Calculated as infarct mass divided by total left ventricular mass, expressed as a percentage. Range 0% to 100%. Lower values are better. |
| MACE - CEC Adjudicated | 30 days post-procedure | cardiac death, reinfarction or ischemia-driven TLR |
| Target Vessel Failure (TVF) - CEC Adjudicated | 30 days post-procedure | all-cause death, reinfarction or ischemia-driven TVR |
| Cardiac Death - CEC Adjudicated | 30 days post-procedure | — |
| Vascular Death - CEC Adjudicated | 30 days post-procedure | — |
| Non-Cardiovascular Death | 30 days post-procedure | — |
| New-Onset Heart Failure - CEC Adjudicated | 30 days post-procedure | — |
| Heart Failure Requiring Hospitalization - CEC Adjudicated | 30 days post-procedure | — |
| Re-Hospitalization for Previous Heart Failure - CEC Adjudicated | 30 days post-procedure | — |
| Myocardial Infarction - CEC Adjudicated | 30 days post-procedure | — |
| Myocardial Infarction, Spontaneous - CEC Adjudicated | 30 days post-procedure | — |
| Myocardial Infarction, Periprocedural (PCI) - CEC Adjudicated | 30 days post-procedure | — |
| Myocardial Infarction, Periprocedural (CABG) - CEC Adjudicated | 30 days post-procedure | — |
| Myocardial Infarction, STEMI - CEC Adjudicated | 30 days post-procedure | — |
| Myocardial Infarction, NSTEMI - CEC Adjudicated | 30 days post-procedure | — |
| Repeat Angiography/Revascularization - CEC Adjudicated | 30 days post-procedure | — |
| Clinically Driven Target Lesion Revascularization (TLR) - CEC Adjudicated | 30 days post-procedure | — |
| Clinically Driven Target Vessel Revascularization (TVR) - CEC Adjudicated | 30 days post-procedure | — |
| Stent Thrombosis (ARC Criteria) - CEC Adjudicated | 30 days post-procedure | — |
| Definite Stent Thrombosis (ARC Criteria) - CEC Adjudicated | 30 days post-procedure | — |
| Probable Stent Thrombosis (ARC Criteria) - CEC Adjudicated | 30 days post-procedure | — |
| Possible Stent Thrombosis (ARC Criteria) - CEC Adjudicated | 30 days post-procedure | — |
| Neurologic Event (Stroke, TIA) - CEC Adjudicated | 30 days post-procedure | — |
| Hemorrhagic/Vascular Event - CEC Adjudicated | 30 days post-procedure | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGregg W Stone, M.D.
Columbia University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 11.9 |
| Door-to-balloon time | 63 minutes |
| Location of infarct lesion Mid-LAD | 13 participants |
| Location of infarct lesion Proximal LAD | 7 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 18 Participants |
| Symptom onset-to-balloon time | 163 minutes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
None listed