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

NCT03947619 | Active Not Recruiting DMC FDA Device

• 1 other identifier: The STEMI-DTU Trial
• Study Type: interventional
• Target: 527
• Locations: 6 countries
• Sites: 63

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.

Conditions

ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Keywords

Anterior STEMI; ST-Elevated MI; Cardiac Unloading

Outcome Measures

Primary Outcomes (1)

• Infarct Size

  Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging

  3-5 days post-procedure

Secondary Outcomes (9)

• Key Powered Composite Secondary Efficacy Endpoint:

  12 months after the randomization of the last enrolled subject

• Key Secondary Safety Endpoint

  30 days

• Powered Secondary Endpoint:

  3-5 days

• Powered Secondary Endpoints:

  3-5 days

• Powered Secondary Endpoints:

  6 months

Study Arms (2)

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

Control

NO INTERVENTION

Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Interventions

Impella CP® placement prior to reperfusion with Primary PCI DEVICE

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (63)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

HonorHealth Research Institute

Scottsdale, Arizona, 82258, United States

Location

The University of Arizona

Tucson, Arizona, 85724, United States

Location

Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.

Covina, California, 91723, United States

Location

Riverside Community Hospital

Riverside, California, 92501, United States

Location

St. Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Hartford Health Care

Hartford, Connecticut, 06102, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

BayCare Cardiology - Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

Tallahasse Research Institute

Tallahassee, Florida, 32308, United States

Location

AdventHealth - Tampa

Tampa, Florida, 33613, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Wellstar/Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

Location

OSF Saint Francis

Peoria, Illinois, 61614, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Mercy Iowa Heart

West Des Moines, Iowa, 50266, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Spectrum

Grand Rapids, Michigan, 49503, United States

Location

Hackensack Medical Center

Hackensack, New Jersey, 07601, United States

Location

Hackensack Meridian Mountainside Medical Center

Montclair, New Jersey, 07042, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Presbyterian Heart Research Group

Albuquerque, New Mexico, 87106, United States

Location

University of Buffalo Hospital

Buffalo, New York, 14203, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Prisma Health

Columbia, South Carolina, 29207, United States

Location

Greenville Health System

Greenville, South Carolina, 48201, United States

Location

Ballad Health - Wellmont CVA Institute

Kingsport, Tennessee, 37660, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

University of Calgary

Calgary, Alberta, T2N 4ZA, Canada

Location

Hamilton Health Science

Hamilton, Ontario, L8L 2X2, Canada

Location

University of Ottawa Heart Institue

Ottawa, Ontario, K1Y 4W7, Canada

Location

University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

Location

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

West German Heart Center Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, Rhineland-Palatinate, 54290, Germany

Location

Heart Center Dresden

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Jena

Jena, D-07747, Germany

Location

University Hospital of Marburg

Marburg, 35043, Germany

Location

Heinrich-Braun-Klinikum Zwickau

Zwickau, 08060, Germany

Location

Ospedale Policlinico San Martino

Genoa, Liguria, 16132, Italy

Location

San Raffaele

Milan, Lombardy, 20132, Italy

Location

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Veneto, 37126, Italy

Location

Humanitas Clinical &amp; Research Hospital

Rozzano, 20089, Italy

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Harefield Hospital

Harefield, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• William O'Neill, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

• Norman Mangner, Prof. Dr. med. habil.

  Heart Center Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of the operator and patient is not possible given the nature of the treatment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, randomized, controlled open-label two-arm trial with an adaptive design

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 13, 2019
• Study Start: December 12, 2019
• Primary Completion: September 4, 2024
• Study Completion (Estimated): October 1, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

GB (1); CH (1); DE (8); US (46); CA (3); IT (4)