Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
- Conditions
- ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
- Interventions
- Device: Impella CP® placement prior to reperfusion with Primary PCI
- Registration Number
- NCT03947619
- Lead Sponsor
- Abiomed Inc.
- Brief Summary
The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.
- Detailed Description
To demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty-minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 668
- Age 18-85 years
- First myocardial infarction
- Acute anterior STEMI with ≥2 mm in 2 or more contiguous anterior leads or ≥ 4 mm total ST segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
- Patient presents to the enrolling hospital where the index procedure will be performed between 1 - 6 hours after onset of continuous ischemic pain
- Patient indicated for Primary PCI
- Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent
-
Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
-
Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition, or any global or focal neurological deficit
-
Administration of fibrinolytic therapy within 24 hours prior to enrollment
-
Cardiogenic shock defined as: systemic hypotension (systolic BP <90 mmHg or the need for inotropes/pressors to maintain a systolic BP >90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end organ hypoperfusion or use of IABP or any other circulatory support device
-
Inferior STEMI or suspected right ventricular failure
-
Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses
-
Severe aortic stenosis
-
Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation
-
Suspected or known pregnancy
-
Suspected systemic active infection
-
History or known hepatic insufficiency prior to catheterization
-
On renal replacement therapy
-
COPD with home oxygen therapy or on chronic steroid therapy
-
Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads
-
Prior CABG or LAD PCI
-
History of heart failure (documented history of EF <40% or documented hospitalization for HF within one (1) year prior to screening)
-
Prior aortic valve surgery or TAVR
-
Left bundle branch block (new or old)
-
History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit
-
History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions
-
Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)
Known contraindication to:
-
Undergoing MRI or use of gadolinium, [CrCl<30 ml/min, non-compatible implant, claustrophobia]
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Heparin, pork, pork products or contrast media
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Receiving a drug-eluting stent
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Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint.
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Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, severe cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study or that, in the opinion of the Investigator and/or Sponsor's medical monitor, would pose an unacceptable risk to the patient in the study.
-
Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures, including follow-up CMRs.
-
Subject belongs to a vulnerable population [Vulnerable patient populations are defined as Individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, prisoners, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, and members of the armed forces.
- A pregnancy test will be conducted prior to enrollment if required by Institutional Review Board (IRB), Regional Ethics Board (REB), local Ethics Committee (EC) or competent authority.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Experimental Impella CP® placement prior to reperfusion with Primary PCI Subjects randomized to the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device prior to PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
- Primary Outcome Measures
Name Time Method Infarct Size 3-5 days post-procedure Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
- Secondary Outcome Measures
Name Time Method Infarct Size, as a percent of Left Ventricular Mass 3-5 days Efficacy- Composite clinical secondary endpoint, Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Impella CP® related Major Bleeding and Major Vascular complications 30 Days Efficacy (Cardiogenic Shock)- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. Secondary Safety (Major Bleeding and Vascular Complications); with pre-specified performance goals.
Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement 12 Months Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Trial Locations
- Locations (64)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States
The University of Arizona
🇺🇸Tucson, Arizona, United States
Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
🇺🇸Covina, California, United States
Riverside Community Hospital
🇺🇸Riverside, California, United States
St. Anthony Hospital
🇺🇸Lakewood, Colorado, United States
Hartford Health Care
🇺🇸Hartford, Connecticut, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
BayCare Cardiology - Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Baptist Health Research Institute
🇺🇸Jacksonville, Florida, United States
Tallahasse Research Institute
🇺🇸Tallahassee, Florida, United States
AdventHealth - Tampa
🇺🇸Tampa, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Wellstar/Kennestone Hospital
🇺🇸Marietta, Georgia, United States
North Shore University Health System
🇺🇸Evanston, Illinois, United States
Midwest Cardiovascular Institute
🇺🇸Naperville, Illinois, United States
OSF Saint Francis
🇺🇸Peoria, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Mercy Iowa Heart
🇺🇸West Des Moines, Iowa, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
Spectrum
🇺🇸Grand Rapids, Michigan, United States
Concord Hospital
🇺🇸Concord, New Hampshire, United States
Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
Hackensack Meridian Mountainside Medical Center
🇺🇸Montclair, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick,, New Jersey, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Presbyterian Heart Research Group
🇺🇸Albuquerque, New Mexico, United States
University of Buffalo Hospital
🇺🇸Buffalo, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
NYU School of Medicine
🇺🇸New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Prisma Health
🇺🇸Columbia, South Carolina, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Ballad Health - Wellmont CVA Institute
🇺🇸Kingsport, Tennessee, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Methodist Hospital
🇺🇸San Antonio, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Hamilton Health Science
🇨🇦Hamilton, Ontario, Canada
University of Ottawa Heart Institue
🇨🇦Ottawa, Ontario, Canada
University Hospital Würzburg
🇩🇪Würzburg, Bavaria, Germany
University Hospital Düsseldorf
🇩🇪Dusseldorf, NRW, Germany
West German Heart Center Essen
🇩🇪Essen, NRW, Germany
Krankenhaus der Barmherzigen Brüder Trier
🇩🇪Trier, RP, Germany
Heart Center Dresden
🇩🇪Dresden, Saxony, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
University Hospital of Marburg
🇩🇪Marburg, Germany
Heinrich-Braun-Klinikum Zwickau
🇩🇪Zwickau, Germany
Ospedale Policlinico San Martino
🇮🇹Genova, Liguria, Italy
San Raffaele
🇮🇹Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Integrata Di Verona
🇮🇹Verona, Veneto, Italy
Humanitas Clinical & Research Hospital
🇮🇹Rozzano, Italy
Luzerner Kantonsspital
🇨🇭Lucerne, Switzerland
Harefield Hospital
🇬🇧Harefield, United Kingdom