- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02603835
Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT) (IC-HOT)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35801
- Heart Center, Inc.
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California
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La Jolla, California, United States, 92037
- Scripps Hospital
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Connecticut
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Danbury, Connecticut, United States, 06801
- Danbury Hospital
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Illinois
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Elk Grove Village, Illinois, United States, 60007
- Alexian Brothers Heart & Vascular Institute
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Massachusetts
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Medical Center
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Detroit, Michigan, United States, 48236
- St. John Hospital & Medical Center
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Royal Oak, Michigan, United States, 48073
- Beaumont Hospital
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Southfield, Michigan, United States, 48075
- Providence-Providence Park Hospital
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North Carolina
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Raleigh, North Carolina, United States, 27610
- WakeMed Heart Center
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Pennsylvania
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Allentown, Pennsylvania, United States, 18101
- Lehigh Valley Hospital
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Camp Hill, Pennsylvania, United States, 17011
- Holy Spirit Cardiology
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02906
- The Miriam Hospital/Rhode Island Hospital
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Tennessee
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Kingsport, Tennessee, United States, 37660
- Wellmont CVA Heart Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
GENERAL INCLUSION CRITERIA: Candidates for this study must meet ALL of the following criteria:
Pre-PCI:
- The subject must be ≥18 and ≤80 years of age.
- 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).
- Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration from time of symptom onset until admission to the emergency room.
- 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).
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:
- 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.
- 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).
- Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.
- 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.
- 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:
- Prior CABG surgery.
- 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).
- Thrombolytic therapy administered for this STEMI.
- An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first 30 days post-enrollment.
- Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the anterior AMI.
- Subjects who have previously undergone an angioplasty or stenting procedure in the left anterior descending coronary artery.
- Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation (with or without papillary muscle rupture).
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.
- Known impaired renal function (creatinine clearance <30 ml/min/1.73 m2
- Known platelet count <100,000 cells/mm by the MDRD formula) or on dialysis. 3 or >700,000 cells/mm3
- 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.
- History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke.
- Stroke or transient ischemic attack within the past six (6) months, or any permanent neurological defect.
- Gastrointestinal or genitourinary bleeding within the last two (2) months, or any major surgery (including CABG) within six weeks of enrollment.
- Subject has received any organ transplant or is on a waiting list for any organ transplant.
- 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.
- Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, cangrelor, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated.
- Current use of warfarin, dabigatran, or factor Xa inhibitors, or known intent to administer these agents after the primary PCI.
- 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.
- Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy.
- 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.).
- Current participation in other investigational device or drug trials that have not finished the primary endpoint follow-up period.
Previous enrollment in this study.
ANGIOGRAPHIC EXCLUSION CRITERIA: These are evaluated after the subject has provided signed Informed Consent but prior to enrollment:
- Anticipated inability to achieve a stable coaxial position in the left main coronary artery with the SSO2 delivery catheter.
- Treatment during the index procedure of any lesion in either the left main, LCX (including the ramus), and/or RCA.
- 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.
- Anterior MI is due to thrombosis within or adjacent to a previously implanted stent.
- Left ventriculography demonstrates severe mitral regurgitation, a ventricular septal defect, or a pseudoaneurysm.
- Any left main coronary artery stenosis >20%.
- 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.
- Presence of a non-stented coronary dissection with NHLBI grade >B upon completion of the PCI procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Net Adverse Clinical Events (NACE)
Time Frame: 30-Day
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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.
This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two event types they are only counted once in the overall NACE rate.
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30-Day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Target Lesion Failure
Time Frame: 30 days
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Composite of cardiac death , target vessel MI, or clinically driven target Lesion revascularization
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30 days
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Rate of Net Adverse Clinical Events (NACE)
Time Frame: 1 year
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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.
This outcome measure includes a hierarchical sum of the events, meaning if a subject experiences two or more event types they are only counted once in the overall NACE rate.
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1 year
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Target Lesion Failure
Time Frame: 1 year
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Composite of cardiac death , target vessel MI, or clinically driven target Lesion revascularization
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1 year
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Median Infarct Size by Cardiac MRI
Time Frame: 30 days
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Measurement of the % left ventricle (LV) necrosis
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30 days
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Microvascular Obstruction by Cardiac MRI
Time Frame: 4 days post-procedure
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Measurement of the % left ventricle (LV) showing microvascular obstruction
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4 days post-procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregg W. Stone, MD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- PCI
- Stents
- Stent
- Myocardial infarction
- Percutaneous coronary intervention
- Angioplasty
- Acute myocardial infarction
- Stenting
- Left main coronary artery
- Heart attack
- Anterior myocardial infarction
- SSO2 Therapy
- SuperSaturated oxygen delivery
- Cardiac catheterization laboratory
- LMCA
- Delivery of supersaturated oxygen (SSO2) therapy for the treatment of anterior acute myocardial infarction
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDE G120029/S007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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