Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
NCT ID: NCT03947619
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
527 participants
INTERVENTIONAL
2019-12-12
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Experimental
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.
Impella CP® placement prior to reperfusion with Primary PCI
Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.
Control
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
No interventions assigned to this group
Interventions
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Impella CP® placement prior to reperfusion with Primary PCI
Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.
Eligibility Criteria
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Inclusion Criteria
2. First myocardial infarction
3. 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
4. Patient presents to the enrolling hospital where the index procedure will be performed between 1 - 6 hours after onset of continuous ischemic pain
5. Patient indicated for Primary PCI
6. Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent
Exclusion Criteria
2. 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
3. Administration of fibrinolytic therapy within 24 hours prior to enrollment
4. 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
5. Inferior STEMI or suspected right ventricular failure
6. Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses
7. Severe aortic stenosis
8. Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation
9. Suspected or known pregnancy
10. Suspected systemic active infection
11. History or known hepatic insufficiency prior to catheterization
12. On renal replacement therapy
13. COPD with home oxygen therapy or on chronic steroid therapy
14. Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads
15. Prior CABG or LAD PCI
16. History of heart failure (documented history of EF \<40% or documented hospitalization for HF within one (1) year prior to screening)
17. Prior aortic valve surgery or TAVR
18. Left bundle branch block (new or old)
19. History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit
20. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions
21. Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)
Known contraindication to:
22. Undergoing MRI or use of gadolinium, \[CrCl\<30 ml/min, non-compatible implant, claustrophobia\]
23. Heparin, pork, pork products or contrast media
24. Receiving a drug-eluting stent
25. 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.
26. 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.
27. 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.
28. 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.
18 Years
85 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William O'Neill, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital
Norman Mangner, Prof. Dr. med. habil.
Role: PRINCIPAL_INVESTIGATOR
Heart Center Dresden
Locations
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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 D.C., 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
Hackensack Medical Center
Hackensack, New Jersey, United States
Hackensack Meridian Mountainside Medical Center
Montclair, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, 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
Düsseldorf, North Rhine-Westphalia, Germany
West German Heart Center Essen
Essen, North Rhine-Westphalia, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, Rhineland-Palatinate, 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
Genoa, 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
Countries
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Other Identifiers
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The STEMI-DTU Trial
Identifier Type: -
Identifier Source: org_study_id
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