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

Running, not enrolling · Not applicable

Conditions studied: ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

In brief

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.

Key facts

Study ID

NCT03947619

Run by

Abiomed Inc.

People needed

527

Starts

2019-12-12

Expected to finish

2030-10-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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