Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart pump before angioplasty may limit attack damage

NCT ID NCT03947619

Disease control Sponsor: Abiomed Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if using a temporary heart pump (Impella CP) for 30 minutes before opening a blocked artery can reduce heart muscle damage in people having a severe heart attack. About 527 adults with a first-time anterior heart attack are enrolled. The goal is to see if this approach works better than the usual immediate artery-opening procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

527 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for ST elevation (stemi) myocardial infarction of anterior wall are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ST elevation (stemi) myocardial infarction of anterior wall

Contacts and locations

Locations

  • AdventHealth - Tampa

    Tampa, Florida, 33613, United States

  • Ascension St. John Hospital

    Detroit, Michigan, 48236, United States

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Veneto, 37126, Italy

  • Ballad Health - Wellmont CVA Institute

    Kingsport, Tennessee, 37660, United States

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207, United States

  • BayCare Cardiology - Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Christiana Care Health Services

    Newark, Delaware, 19718, United States

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

    Covina, California, 91723, United States

  • George Washington University

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

  • Greenville Health System

    Greenville, South Carolina, 48201, United States

  • Hackensack Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hackensack Meridian Mountainside Medical Center

    Montclair, New Jersey, 07042, United States

  • Hamilton Health Science

    Hamilton, Ontario, L8L 2X2, Canada

  • Harefield Hospital

    Harefield, United Kingdom

  • Hartford Health Care

    Hartford, Connecticut, 06102, United States

  • Heart Center Dresden

    Dresden, Saxony, 01307, Germany

  • Heinrich-Braun-Klinikum Zwickau

    Zwickau, 08060, Germany

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • HonorHealth Research Institute

    Scottsdale, Arizona, 82258, United States

  • Humanitas Clinical &amp; Research Hospital

    Rozzano, 20089, Italy

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Kettering Medical Center

    Kettering, Ohio, 45429, United States

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, Rhineland-Palatinate, 54290, Germany

  • Luzerner Kantonsspital

    Lucerne, Switzerland

  • Mercy Iowa Heart

    West Des Moines, Iowa, 50266, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540, United States

  • NYU School of Medicine

    New York, New York, 10016, United States

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102, United States

  • North Shore University Health System

    Evanston, Illinois, 60201, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • OSF Saint Francis

    Peoria, Illinois, 61614, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132, Italy

  • Presbyterian Heart Research Group

    Albuquerque, New Mexico, 87106, United States

  • Prisma Health

    Columbia, South Carolina, 29207, United States

  • Riverside Community Hospital

    Riverside, California, 92501, United States

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • San Raffaele

    Milan, Lombardy, 20132, Italy

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794, United States

  • Spectrum

    Grand Rapids, Michigan, 49503, United States

  • St. Anthony Hospital

    Lakewood, Colorado, 80228, United States

  • Tallahasse Research Institute

    Tallahassee, Florida, 32308, United States

  • The University of Arizona

    Tucson, Arizona, 85724, United States

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • University Hospital Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • University Hospital Würzburg

    Würzburg, Bavaria, 97080, Germany

  • University Hospital of Marburg

    Marburg, 35043, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Buffalo Hospital

    Buffalo, New York, 14203, United States

  • University of Calgary

    Calgary, Alberta, T2N 4ZA, Canada

  • University of Ottawa Heart Institue

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Universitätsklinikum Jena

    Jena, D-07747, Germany

  • Wellstar/Kennestone Hospital

    Marietta, Georgia, 30060, United States

  • West German Heart Center Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506, United States