Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)

NCT ID: NCT02603835

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-05-17

Brief Summary

The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful percutaneous coronary intervention (PCI) with stenting within six hours of experiencing AMI symptoms.

Detailed Description

A Multi-Center, Consecutively Enrolled Single-Arm Study to confirm the safety and effectiveness of the delivery of supersaturated oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA) with a commercially available qualified SSO2 delivery catheter used with the TherOx® DownStream® System and Cartridge in the treatment of qualified patients presenting with anterior acute myocardial infarction in whom reperfusion with PCI is successful within six hours after symptom onset.

Conditions

Anterior Wall Acute Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SSO2 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

Group Type: EXPERIMENTAL

SSO2 Therapy

Intervention Type: DEVICE

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

Interventions

SSO2 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

Intervention Type: DEVICE

Other Intervention Names

TherOx DownStream System; TherOx DownStream Cartridge; SSO2 Delivery Catheter

Eligibility Criteria

Inclusion Criteria

Pre-PCI:

1. The subject must be ≥18 and ≤80 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. Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration from time of symptom onset until admission to the emergency room.

4. 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).

5. Subject and his/her physician agree to all required follow-up procedures and visits.

6. 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) in the LAD.

7. The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery (other lesions in the LAD target vessel, including diagonal branches, may be treated if clinically indicated).

8. Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.

9. Successful angioplasty as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow and no major complications such as perforation or shock.

10. 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.

Exclusion Criteria

Pre-PCI:

1. Prior CABG surgery.

2. Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction <40% by any prior measure or regional wall motion abnormalities; this criterion does not include left ventricular dysfunction induced by the acute MI).

3. Thrombolytic therapy administered for this STEMI.

4. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment.

5. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.

6. Subjects who have previously undergone an angioplasty or stenting procedure in the left anterior descending coronary artery.

7. Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).

8. Any contraindication to MRI imaging. This will include any of the following exclusions:

• Cardiac pacemaker or implantable defibrillator;
• Non-MRI compatible aneurysm clip;
• 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 metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
• Any history indicating contraindication to MRI, including claustrophobia or allergy to gadolinium;
• Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and
• Known hypersensitivity or contraindication to gadolinium contrast.

9. Known impaired renal function (creatinine clearance <30 ml/min/1.73 m2

10. Known platelet count <100,000 cells/mm by the MDRD formula) or on dialysis. 3 or >700,000 cells/mm3

11. Subject has active bleeding or a history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary. or a known Hgb <10 g/dL.

12. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.

13. Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.

14. Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment.

15. Subject has received any organ transplant or is on a waiting list for any organ transplant.

16. 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 limited life expectancy of less than one year.

17. Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, cangrelor, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated.

18. Current use of warfarin, dabigatran, or factor Xa inhibitors, or known intent to administer these agents after the primary PCI.

19. Subjects presenting with or developing in the cath lab prior to completion of the primary 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.

20. Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy.

21. 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.).

22. Current participation in other investigational device or drug trials that have not finished the primary endpoint follow-up period.

23. Previous enrollment in this study.

24. Anticipated inability to achieve a stable coaxial position in the left main coronary artery with the SSO2 delivery catheter.

25. Treatment during the index procedure of any lesion in either the left main, LCX (including the ramus), and/or RCA.

26. Post-index procedure planned intervention within 30 days (i.e., PCI of non-target lesions in any vessel, or CABG). Note: Planned revascularization (PCI or bypass) of a non-target lesion >30 days following the index procedure is allowed.

27. Anterior MI is due to thrombosis within or adjacent to a previously implanted stent.

28. Left ventriculography demonstrates severe mitral regurgitation, a ventricular septal defect, or a pseudoaneurysm.

29. Any left main coronary artery stenosis >20%.

30. Any untreated LAD or diagonal branch lesion is present with diameter stenosis > 50% in a vessel with reference vessel diameter > 2.0 mm (visually estimated), or for which PCI will be required before the MRI study.

31. Presence of a non-stented coronary dissection with NHLBI grade >B upon completion of the PCI procedure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TherOx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregg W. Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Heart Center, Inc.

Huntsville, Alabama, United States

Scripps Hospital

La Jolla, California, United States

Danbury Hospital

Danbury, Connecticut, United States

Alexian Brothers Heart & Vascular Institute

Elk Grove Village, Illinois, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Henry Ford Medical Center

Detroit, Michigan, United States

St. John Hospital & Medical Center

Detroit, Michigan, United States

Beaumont Hospital

Royal Oak, Michigan, United States

Providence-Providence Park Hospital

Southfield, Michigan, United States

WakeMed Heart Center

Raleigh, North Carolina, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Holy Spirit Cardiology

Camp Hill, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

The Miriam Hospital/Rhode Island Hospital

Providence, Rhode Island, United States

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Countries

United States

References

Chen S, David SW, Khan ZA, Metzger DC, Wasserman HS, Lotfi AS, Hanson ID, Dixon SR, LaLonde TA, Genereux P, Ozan MO, Maehara A, Stone GW. One-year outcomes of supersaturated oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2021 May 1;97(6):1120-1126. doi: 10.1002/ccd.29090. Epub 2020 Jul 10.

Reference Type: DERIVED

PMID: 32649037 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IDE G120029/S007

Identifier Type: -

Identifier Source: org_study_id