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ST Elevation (STEMI) Myocardial Infarction of Anterior WallDTU-STEMINCT03947619

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

A study testing Impella CP® placement prior to reperfusion with Primary PCI in people with ST Elevation (STEMI) Myocardial Infarction of Anterior Wall, run by Abiomed Inc. at 63 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Impella CP® placement prior to reperfusion with Primary PCI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
527 participants
Where
63 sitesin 6 countries
Study dates
12 Dec 2019to Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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]
  • Heparin, pork, pork products or contrast media
  • Receiving a drug-eluting stent
  • 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.
  • 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.

Trial locations and contacts

63 sites in 6 countries.

63 sites in 6 countries

United States46 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Presbyterian Heart Research Group

    Albuquerque, New Mexico, 87106

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • University of Buffalo Hospital

    Buffalo, New York, 14203

  • BayCare Cardiology - Morton Plant Hospital

    Clearwater, Florida, 33756

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Prisma Health

    Columbia, South Carolina, 29207

  • Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.

    Covina, California, 91723

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension St. John Hospital

    Detroit, Michigan, 48236

  • North Shore University Health System

    Evanston, Illinois, 60201

  • Spectrum

    Grand Rapids, Michigan, 49503

  • Greenville Health System

    Greenville, South Carolina, 48201

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601

  • Hartford Health Care

    Hartford, Connecticut, 06102

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Ballad Health - Wellmont CVA Institute

    Kingsport, Tennessee, 37660

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • St. Anthony Hospital

    Lakewood, Colorado, 80228

  • Northwell Health

    Manhasset, New York, 11030

  • Wellstar/Kennestone Hospital

    Marietta, Georgia, 30060

  • Hackensack Meridian Mountainside Medical Center

    Montclair, New Jersey, 07042

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • NYU School of Medicine

    New York, New York, 10016

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • OSF Saint Francis

    Peoria, Illinois, 61614

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Riverside Community Hospital

    Riverside, California, 92501

  • Methodist Hospital

    San Antonio, Texas, 78229

  • HonorHealth Research Institute

    Scottsdale, Arizona, 82258

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794

  • Tallahasse Research Institute

    Tallahassee, Florida, 32308

  • AdventHealth - Tampa

    Tampa, Florida, 33613

  • The University of Arizona

    Tucson, Arizona, 85724

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • George Washington University

    Washington D.C., District of Columbia, 20037

  • Mercy Iowa Heart

    West Des Moines, Iowa, 50266

Other trials in United States

Germany8 sites

  • Heart Center Dresden

    Dresden, Saxony, 01307

  • University Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • West German Heart Center Essen

    Essen, North Rhine-Westphalia, 45147

  • Universitätsklinikum Jena

    Jena, D-07747

  • University Hospital of Marburg

    Marburg, 35043

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, Rhineland-Palatinate, 54290

  • University Hospital Würzburg

    Würzburg, Bavaria, 97080

  • Heinrich-Braun-Klinikum Zwickau

    Zwickau, 08060

Other trials in Germany

Italy4 sites

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • San Raffaele

    Milan, Lombardy, 20132

  • Humanitas Clinical &amp; Research Hospital

    Rozzano, 20089

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Veneto, 37126

Other trials in Italy

Canada3 sites

  • University of Calgary

    Calgary, Alberta, T2N 4ZA

  • Hamilton Health Science

    Hamilton, Ontario, L8L 2X2

  • University of Ottawa Heart Institue

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

Switzerland1 site

  • Luzerner Kantonsspital

    Lucerne

Other trials in Switzerland

United Kingdom1 site

  • Harefield Hospital

    Harefield

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
Impella CP® placement prior to reperfusion with Primary PCI
Keywords
Anterior STEMI, ST-Elevated MI, Cardiac Unloading
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Impella CP® placement prior to reperfusion with Primary PCIDevice

    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.

Study groups in NCT03947619
Study groupRoleWhat they receive
ExperimentalExperimentalSubjects 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.
Receives: Device: Impella CP® placement prior to reperfusion with Primary PCI
ControlNo interventionPrimary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Infarct Size

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

    Measured: 3-5 days post-procedure

Secondary outcomes (9)

  1. Key Powered Composite Secondary Efficacy Endpoint:

    Compared between groups using Finkelstein- Schoenfeld statistic at 12 months after the randomization of the last enrolled subject.

    1. Cardiovascular mortality
    2. Cardiogenic shock at ≥24 hours after enrollment
    3. LVAD or heart transplant
    4. Heart failure (HF)-related hospitalization/urgent care visit
    5. ICD or CRT placement
    6. Infarct size, as a percent of LV mass [Time Frame: 3-5 days]

    Measured: 12 months after the randomization of the last enrolled subject

  2. Key Secondary Safety Endpoint

    Impella CP-related major bleeding or major vascular complications (compared to a pre-specified performance goals).

    Measured: 30 days

  3. Powered Secondary Endpoint:

    Infarct size as a percentage of area-at-risk (AAR)

    Measured: 3-5 days

  4. Powered Secondary Endpoints:

    Percent microvascular obstruction (%MVO)

    Measured: 3-5 days

  5. Powered Secondary Endpoints:

    Left ventricular end-systolic volume (LVESV)

    Measured: 6 months

  6. Powered Secondary Endpoints:

    Left ventricular end-diastolic volume (LVEDV)

    Measured: 6 months

  7. Powered Secondary Endpoints:

    Left ventricular end-systolic volume index (LVESVi)

    Measured: 90 days

  8. Powered Secondary Endpoints:

    Left ventricular end-diastolic volume index (LVEDVi)

    Measured: 90 days

  9. Powered Secondary Endpoints:

    Ejection fraction (EF)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2019
  2. Study start12 Dec 2019
  3. Primary completion4 Sep 2024
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
A prospective, multicenter, randomized, controlled open-label two-arm trial with an adaptive design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
527 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03947619
Sponsor's protocol ID
The STEMI-DTU Trial
Acronym
DTU-STEMI
Status last verified
Mar 2026
First submitted
6 May 2019
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Kapur NK, Mangner N, Aghili N, Faraz H, McElwee S, Nazir R, Chieffo A, Jolly S, Bieniarz M, Cuculi F, George Z, Katopodis J, Manly D, Metzger C, Noel T, Polzin A, Rana G, Rengifo-Moreno P, Westenfeld R, Bossard M, Nordbeck P, Reddy N, Woitek F, Yau R, Facemire C, Parikh A, Gao Y, Awad H, Moretz J, Christanday G, Sood P, Bilazarian S, Simonton CA, Han Y, Marx SO, Burkhoff D, Udelson J, Moses J, Kimmelstiel C, Karas R, Stone GW, O'Neill W. Left Ventricular Unloading in Anterior ST-Segment Elevation Myocardial Infarction Without Shock: The ST-Segment Elevation Myocardial Infarction Door to Unload Randomized Controlled Trial. J Am Coll Cardiol. 2026 Jul 7;88(1):76-90. doi: 10.1016/j.jacc.2026.03.071. Epub 2026 Mar 28.

    PubMed 42029358

Questions about this trial

What is this clinical trial studying?

A study testing Impella CP® placement prior to reperfusion with Primary PCI in people with ST Elevation (STEMI) Myocardial Infarction of Anterior Wall, run by Abiomed Inc. at 63 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Germany, Italy, Canada, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Infarct Size (time frame: 3-5 days post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03947619, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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