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

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ClinicalTrials.gov Identifier: NCT02603835
Recruitment Status : Unknown
Verified September 2017 by TherOx.
Recruitment status was:  Active, not recruiting
First Posted : November 13, 2015
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
TherOx

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.

Condition or disease Intervention/treatment Phase
Anterior Wall Acute Myocardial Infarction Device: SSO2 Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Evaluation of the Delivery of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy for 60 Minutes in Anterior Acute Myocardial Infarction Patients With Successful Reperfusion (Via PCI) ≤ Six Hours After Symptom Onset
Actual Study Start Date : February 2016
Actual Primary Completion Date : August 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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
Device: 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
Other Names:
  • TherOx DownStream System
  • TherOx DownStream Cartridge
  • SSO2 Delivery Catheter




Primary Outcome Measures :
  1. Net Adverse Clinical Events (NACE) [ Time Frame: 30-Day ]
    Composite of death, reinfarction, clinically-driven target vessel revascularization, stent thrombosis (ARC definite or probable), new onset severe heart failure or readmission for heart failure, and TIMI major or minor bleeding



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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.

    ANGIOGRAPHIC INCLUSION CRITERIA: These are evaluated after the subject has provided signed informed consent but prior to enrollment:

  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.

GENERAL 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.

    ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603835


Locations
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United States, Alabama
Heart Center, Inc.
Huntsville, Alabama, United States, 35801
United States, California
Scripps Hospital
La Jolla, California, United States, 92037
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06801
United States, Illinois
Alexian Brothers Heart & Vascular Institute
Elk Grove Village, Illinois, United States, 60007
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
St. John Hospital & Medical Center
Detroit, Michigan, United States, 48236
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Providence-Providence Park Hospital
Southfield, Michigan, United States, 48075
United States, North Carolina
WakeMed Heart Center
Raleigh, North Carolina, United States, 27610
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18101
Holy Spirit Cardiology
Camp Hill, Pennsylvania, United States, 17011
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, Rhode Island
The Miriam Hospital/Rhode Island Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
Sponsors and Collaborators
TherOx
Investigators
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Principal Investigator: Gregg W. Stone, MD Columbia University

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Responsible Party: TherOx
ClinicalTrials.gov Identifier: NCT02603835     History of Changes
Other Study ID Numbers: IDE G120029/S007
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by TherOx:
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
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases