Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial (DTU-STEMI)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
• Intervention / Treatment: Device: Impella CP® placement prior to reperfusion with Primary PCI

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.

• Study Type: Interventional
• Enrollment (Actual): 527
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4ZA
      • University of Calgary
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Science
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institue
• Germany
  • Jena, Germany, D-07747
    • Universitatsklinikum Jena
  • Marburg, Germany, 35043
    • University Hospital of Marburg
  • Zwickau, Germany, 08060
    • Heinrich-Braun-Klinikum Zwickau
  • Bavaria
    • Würzburg, Bavaria, Germany, 97080
      • University Hospital Wurzburg
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • University Hospital Düsseldorf
    • Essen, North Rhine-Westphalia, Germany, 45147
      • West German Heart Center Essen
  • Rhineland-Palatinate
    • Trier, Rhineland-Palatinate, Germany, 54290
      • Krankenhaus der Barmherzigen Bruder Trier
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Heart Center Dresden
• Italy
  • Rozzano, Italy, 20089
    • Humanitas Clinical & Research Hospital
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Ospedale Policlinico San Martino
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • San Raffaele
  • Veneto
    • Verona, Veneto, Italy, 37126
      • Azienda Ospedaliera Universitaria Integrata di Verona
• Switzerland
  • Lucerne, Switzerland
    • Luzerner Kantonsspital
• United Kingdom
  • Harefield, United Kingdom
    • Harefield Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 82258
      • HonorHealth Research Institute
    • Tucson, Arizona, United States, 85724
      • The University of Arizona
  • California
    • Covina, California, United States, 91723
      • Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.
    • Riverside, California, United States, 92501
      • Riverside Community Hospital
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • St. Anthony Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Health Care
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Health Services
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • George Washington University
  • Florida
    • Clearwater, Florida, United States, 33756
      • BayCare Cardiology - Morton Plant Hospital
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Research Institute
    • Tallahassee, Florida, United States, 32308
      • Tallahasse Research Institute
    • Tampa, Florida, United States, 33613
      • AdventHealth - Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Marietta, Georgia, United States, 30060
      • Wellstar/Kennestone Hospital
  • Illinois
    • Evanston, Illinois, United States, 60201
      • North Shore University Health System
    • Naperville, Illinois, United States, 60540
      • Midwest Cardiovascular Institute
    • Peoria, Illinois, United States, 61614
      • OSF Saint Francis
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University School of Medicine
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Mercy Iowa Heart
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Medical Center
    • Montclair, New Jersey, United States, 07042
      • Hackensack Meridian Mountainside Medical Center
    • Neptune City, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
    • Albuquerque, New Mexico, United States, 87106
      • Presbyterian Heart Research Group
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo Hospital
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • New York, New York, United States, 10016
      • NYU School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
  • South Carolina
    • Columbia, South Carolina, United States, 29207
      • Prisma Health
    • Greenville, South Carolina, United States, 48201
      • Greenville Health System
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Ballad Health - Wellmont CVA Institute
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-85 years
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:

1. Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
No Intervention: Control; Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct Size	Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging	3-5 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Powered Composite Secondary Efficacy Endpoint:	Compared between groups using Finkelstein- Schoenfeld statistic at 12 months after the randomization of the last enrolled subject.; Cardiovascular mortality; Cardiogenic shock at ≥24 hours after enrollment; LVAD or heart transplant; Heart failure (HF)-related hospitalization/urgent care visit; ICD or CRT placement; Infarct size, as a percent of LV mass [Time Frame: 3-5 days]	12 months after the randomization of the last enrolled subject
Key Secondary Safety Endpoint	Impella CP-related major bleeding or major vascular complications (compared to a pre-specified performance goals).	30 days
Powered Secondary Endpoint:	Infarct size as a percentage of area-at-risk (AAR)	3-5 days
Powered Secondary Endpoints:	Percent microvascular obstruction (%MVO)	3-5 days
Powered Secondary Endpoints:	Left ventricular end-systolic volume (LVESV)	6 months
Powered Secondary Endpoints:	Left ventricular end-diastolic volume (LVEDV)	6 months
Powered Secondary Endpoints:	Left ventricular end-systolic volume index (LVESVi)	90 days
Powered Secondary Endpoints:	Left ventricular end-diastolic volume index (LVEDVi)	90 days
Powered Secondary Endpoints:	Ejection fraction (EF)	6 months

Collaborators and Investigators

• Sponsor: Abiomed Inc.
• Investigators: Principal Investigator: William O'Neill, MD, Henry Ford Hospital; Principal Investigator: Norman Mangner, Prof. Dr. med. habil., Heart Center Dresden

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Actual): September 4, 2024
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anterior STEMI; ST-Elevated MI; Cardiac Unloading
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction
• Other Study ID Numbers: The STEMI-DTU Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No