- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01630707
[Test urządzenia, które nie zostało zatwierdzone lub dopuszczone przez amerykańską FDA]
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Arizona
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Scottsdale, Arizona, Stany Zjednoczone, 85259
- Scottsdale Healthcare
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Michigan
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Royal Oak, Michigan, Stany Zjednoczone, 48703
- Beaumont Hospital, Royal Oak
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Southfield, Michigan, Stany Zjednoczone, 48075
- Providence Hospital and Medical Centers
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Tennessee
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Kingsport, Tennessee, Stany Zjednoczone, 37660
- Wellmont Holston Valley Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
- Subject is experiencing clinical symptoms consistent with anterior AMI of ≤6 hour duration.
- Signed Informed Consent.
- Subject agrees to all required follow-up procedures and visits.
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:
- PCI is indicated for revascularization of the culprit lesion(s) with use of a commercially available coronary stent in the LAD.
- The primary stented infarct-related lesion(s) must be in the proximal and/or mid-LAD coronary artery.
- Baseline (pre-PCI) TIMI flow grade 0, 1, 2, or 3 flow in the LAD.
- Successful angioplasty 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.
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:
- Prior CABG surgery.
- Prior myocardial infarction, or known prior systolic dysfunction.
- 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 angioplasty or stenting in the LAD.
- Subjects with ventricular pseudoaneurysm, VSD, or severe mitral valve regurgitation.
- Any contraindication to undergo MRI imaging.
- Impaired renal function or on dialysis.
- Known platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a known Hgb <10 g/dL.
- Subject has active bleeding or a history of bleeding.
- 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 a may cause non-compliance with the protocol.
- Subject has a known hypersensitivity or contraindication to unfractionated heparin, abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine, prasugrel, or ticagrelor that cannot be adequately premeditated.
- Current use of warfarin, dabigatran, or factor Xa inhibitors.
- Subjects presenting with or developing in the cath lab: cardiogenic shock or ventricular fibrillation or tachycardia.
- Severe known cardiac valvular stenosis or insufficiency, pericardial disease, or non-ischemic cardiomyopathy.
- Any significant medical condition which in the investigator's opinion may interfere with the subject's optimal participation in the study.
- 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:
- Inability to achieve a stable coaxial position in the left main coronary artery with the catheter.
- Treatment during the index procedure of any lesion in the left main, LCX, and/or RCA.
- Coronary anatomy such that coronary artery bypass graft surgery is indicated within 30 days.
- Post-index procedure planned intervention within 30 days.
- Anatomic features are present which are highly unfavorable for PCI.
- 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 or for which PCI will be required before the MRI study.
- Presence of a non-stented coronary dissection upon completion of the PCI procedure.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Optimized SSO2 Therapy
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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
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The Feasibility of Intracoronary Infusion of SSO2 Therapy
Ramy czasowe: Procedure
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Successful administration of SSO2 Therapy (60 minutes) without dislodgment of the SSO2 delivery catheter during the infusion and without untoward Serious Adverse Events
|
Procedure
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Median Myocardial Salvage Index
Ramy czasowe: 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.
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3 to 5 days post-procedure
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Median Infarct Size by Cardiac MRI
Ramy czasowe: 3 to 5 days post-procedure
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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.
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3 to 5 days post-procedure
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Median Infarct Size by Cardiac MRI
Ramy czasowe: 30 days post-procedure
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Infarct size by cardiac MRI with late gadolinium enhancement at 30 (±7) 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.
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30 days post-procedure
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MACE - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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cardiac death, reinfarction or ischemia-driven TLR
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30 days post-procedure
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Target Vessel Failure (TVF) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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all-cause death, reinfarction or ischemia-driven TVR
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30 days post-procedure
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Cardiac Death - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Vascular Death - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Non-Cardiovascular Death
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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New-Onset Heart Failure - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Heart Failure Requiring Hospitalization - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Re-Hospitalization for Previous Heart Failure - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Myocardial Infarction - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Myocardial Infarction, Spontaneous - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Myocardial Infarction, Periprocedural (PCI) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Myocardial Infarction, Periprocedural (CABG) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Myocardial Infarction, STEMI - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Myocardial Infarction, NSTEMI - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Repeat Angiography/Revascularization - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Clinically Driven Target Lesion Revascularization (TLR) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Clinically Driven Target Vessel Revascularization (TVR) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Definite Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Probable Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Possible Stent Thrombosis (ARC Criteria) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Neurologic Event (Stroke, TIA) - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Hemorrhagic/Vascular Event - CEC Adjudicated
Ramy czasowe: 30 days post-procedure
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30 days post-procedure
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Gregg W Stone, M.D., Columbia University
Publikacje i pomocne linki
Publikacje ogólne
- Stone GW, Martin JL, de Boer MJ, Margheri M, Bramucci E, Blankenship JC, Metzger DC, Gibbons RJ, Lindsay BS, Weiner BH, Lansky AJ, Krucoff MW, Fahy M, Boscardin WJ; AMIHOT-II Trial Investigators. Effect of supersaturated oxygen delivery on infarct size after percutaneous coronary intervention in acute myocardial infarction. Circ Cardiovasc Interv. 2009 Oct;2(5):366-75. doi: 10.1161/CIRCINTERVENTIONS.108.840066. Epub 2009 Sep 15.
- Friedewald VE, Gibbons RJ, O'Neill WW, Popma JJ, Stone GW, Roberts WC. The editor's roundtable: intracoronary hyperoxemic therapy in acute myocardial infarction. Am J Cardiol. 2009 Sep 15;104(6):791-7. doi: 10.1016/j.amjcard.2009.06.018. No abstract available.
- Warda HM, Bax JJ, Bosch JG, Atsma DE, Jukema JW, van der Wall EE, van der Laarse A, Schalij MJ, Oemrawsingh PV. Effect of intracoronary aqueous oxygen on left ventricular remodeling after anterior wall ST-elevation acute myocardial infarction. Am J Cardiol. 2005 Jul 1;96(1):22-4. doi: 10.1016/j.amjcard.2005.02.037.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Szacowany)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
- PCI
- przezskórna interwencja wieńcowa
- zawał mięśnia sercowego
- stent
- stentowanie
- stenty
- ostry zawał mięśnia sercowego
- angioplastyka
- zawał serca
- Terapia SSO2
- Dostarczanie tlenu supernasyconego
- LMCA
- Dostarczanie terapii tlenem przesyconym (SSO2) w leczeniu przedniego ostrego zawału mięśnia sercowego
- pracownia cewnikowania serca
- left main coronary artery
- przednia zawał mięśnia sercowego
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IDE G120029
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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